FDA

Enforcement Report

May 5, 1999                                       99-18
RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS 
I
________
PRODUCT
Johnson Sea Products brand Crawfish Patty packed 18 3-ounce 
patties per box and 6 boxes per cardboard case.
Recall #F-367-9.
CODE
All codes on the market which do not list whole eggs as an 
ingredient.
MANUFACTURER
Johnson Sea Products, Inc., Coden, Alabama.
RECALLED BY
Manufacturer, by telephone on March 25, 1999, followed by letter 
on April 1, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Alabama.
QUANTITY
84 cases were distributed; firm estimated that very little 
product remained on market at time of recall initiation.
REASON
Product contains undeclared whole eggs.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS 
II
________
PRODUCT
Solid Dark Chocolate Seder Plate Replicas, kosher for Passover, 
under the Manischewitz label, sold in 6-count 16 ounce plates per 
case.  Recall #F-349-9.
CODE
Lot numbers:  208MB, 122MB, 123MB.
MANUFACTURER
Boyer Candy Company, Altoona, Pennsylvania.
RECALLED BY
Manufacturer, by letter faxed on February 2, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
New Jersey, Arkansas.
QUANTITY
33 cases were distributed.
REASON
Product contains undeclared dairy ingredients.
________
PRODUCT
Master Marine brand 5 pound IQF Shell-On Shrimp Tails, packed 4/5 
pound poly bags per cardboard carton.  All sizes of shrimp 
included.  Recall #F-350-9.
CODE
517-351-98     350-356-98     530-356-98     534-6-99
540-7-99       548-12-99      549-13-99      550-14-99
551-19-99      552-19-99      553-19-99      559-26-99
560-26-99      568-32-99      569-33-99      570-34-99
573-34-99      574-34-99      583-36-99      588-40-99
589-40-99.
MANUFACTURER
International Oceanic Enterprises, Inc., Bayou La Batre, Alabama.
RECALLED BY
Manufacturer, by letter dated March 2, 1999, and by telephone on 
March 9, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
The midwest, and eastern sections of the United States.
QUANTITY
59,620 pounds were distributed.
REASON
Sodium bisulfite declaration on the product labels is 
intermittently illegible.
________
PRODUCT
Harry's Choice brand Hot Beer Cheese packed in 8 ounce glass 
jars.  Recall #F-362-9.
CODE
The product was not coded.
MANUFACTURER
Heritage Fancy Foods, Inc., also known as Dixie Dew Products 
Company, Erlanger, Kentucky.
RECALLED BY
Manufacturer, by telephone on February 3, 1999. Ongoing recall 
resulted from sample analysis and follow-up by the Kentucky 
Department for Public Health, Food Safety Branch.
DISTRIBUTION
Indiana, New York, North Carolina, Kentucky.
QUANTITY
Approximately 186 jars of cheese were distributed.
REASON
Product was prepared and packed under insanitary conditions 
whereby the product may have been rendered injurious to health, 
as the firm did not adhere to canning regulations.
________
PRODUCT
Refrigerated Chocolate Chip Cookie Dough in 18-oz plastic chubs 
(tubes) sold under private labels as follows:
F-363-9 Formulation 0200 under the following labels:
a) LadyLee Soft & Chewy Chocolate Chip Cookies Spoonable Dough, 
distributed by American Procurement & Logistics Company, Salt 
Lake City, UT
b) Parade Classics Soft'n Chewy Chocolate Chip Cookies, packed 
for Federated Foods, Inc., Arlington Heights, IL
c) Piggly Wiggly Chocolate Chip Cookies, distributed by Piggly 
Wiggly Corp., Memphis, TN
d) Price Chopper Soft'n Chewy Chocolate Chip Cookies, distributed 
by The Price Chopper, Schenectady, NY
e) Remarkable Spoonable Cookie Dough Chocolate Chip Soft & Chewy 
Cookies, distributed by Randalls/Tom Thumb Food Markets, Houston, 
TX, Dallas,TX
f) Richfood Ready To Bake Soft'n Chewy Chocolate Chip Cookies, 
distributed by Richfood, Inc., Richmond, VA
g) BestYet Chocolate Chip Spoonable Cookie Dough, distributed by 
Fleming Companies, Inc., Oklahoma City, OK
h) Safeway Chocolate Chip Cookies Spoonable Cookie Dough,
distributed by Safeway Inc., Pleasanton, CA
i) Grand Union Ready to Bake Chocolate Chip Cookies, distributed 
by The Grand Union Co., Wayne, NJ
j) Food Club Chocolate Chip Cookies Traditional, distributed by 
Topco Associates, Inc., Skokie, IL
k) ShurFine Chocolate Chip Cookies, distributed by Western Family 
Foods, Inc., Portland, OR
l) Hannaford Soft and Chewy Chocolate Chip Cookies Spoonable
Cookie Dough, distributed by Hannaford Bros. Co., Scarborough, ME
m) Premium Chocolate Chip Cookies, distributed by Stater Bros. 
Market, Colton, CA
n) Star Soft'n Chewy Chocolate Chip Cookies Spoonable Cookie
Dough, distributed by Star Market Co., Cambridge, MA
o) Springfield Chocolate Chip Premium Cookies, distributed by 
Certified Grocers of California, Ltd., Los Angeles, CA
p) Southern Home Spoonable Cookie Dough Soft & Chewy Cookies
Chocolate Chip, distributed by Southern Home, Birmingham, AL
q) Smith's Soft'n Chewy Chocolate Chip Cookies Spoonable Cookie 
Dough, distributed by Smith's Food & Drug Centers, Inc., Layton, 
UT
r) Wegmans Chocolate Chip Cookies Spoonable Cookie Dough,
distributed by Wegmans Food Markets, Inc., Rochester, NY
s) LiteFluff Soft'N Chewy Chocolate Chip Cookies Spoonable Cookie 
Dough; responsible firm on the label is The Earthgrains Company, 
St.,Louis, MO
t) Dominick's Chocolate Chip Cookies, distributed by Dominick's 
Finer Foods, Inc., Northlake, IL
u) Roundy's Quality Soft & Chewy Chocolate Chip Cookies Spoonable 
Cookie Dough, distributed by Roundy's, Inc., Milwaukee, WI
v) IGA Soft n Chewy Cookies Chocolate Chip, distributed by IGA, 
Inc., Chicago, IL
w) Best Choice Cookie Dough Chocolate chip, distributed by
Associated Wholesale Grocers, Inc., Kansas City, KS
x) Finast Chocolate Chip Cookies, distributed by Foodhold U.S.A., 
Incorporated, Atlanta, GA
y) Western Family Soft'N Chewy Chocolate Chip Cookies,
distributed by Western Family Foods, Inc., Portland, OR
F-364-9 Formulation 0213 under the following labels:
a) Stop & Shop Soft  N' Chewy Chocolate Chip Cookie Dough,
distributed by The Stop & Shop Supermarket Company, Boston, MA
b) Western Beef Chocolate Chip Cookies, distributed by Western 
Beef Supermarkets, Ridgewood, NY
c) Superbrand Soft  N Chewy Classic Cookies Chocolate Chip
Cookies Spoonable Cookie Dough, distributed by Monterey Canning 
Co., San Mateo, CA
d) Shaw's Classic Chocolate Chip Cookie Dough, distributed by 
Shaw's Supermarkets, Inc., E. Bridgewater, MA
e) Shurfresh Spoonable Cookie Dough Soft'N Chewy Chocolate Chip 
Cookies, distributed by Shurfine International, Inc., Northlake, 
IL
f) Grammies Favorites Soft & Chewy Chocolate Chip Cookies
Spoonable Cookie Dough, distributed by Moran Foods, Inc., St. 
Louis, MO
g) Cub Foods Hot & Fresh Chocolate Chip Spoonable Cookie Dough, 
distributed by Preferred Products, Inc., Eden Prairie, MN 
h) America's Choice Chocolate Chip Cookies Soft & Chewy Spoonable 
Dough, distributed by Compass Foods, Montvale, NJ
i) American Fare Soft'n Chewy Cookies Chocolate Chip, made for 
KMart Corporation, Troy, MI
j) Braum's Chocolate Chip Cookie Dough, distributed by W.H.
Braum, Inc., Tuttle, OK
k) Bi-Lo Chocolate Chip Cookies, distributed by Bi-Lo, Inc.,
Mauldin, SC
l) Laura Lynn Chocolate Chip Cookies Soft'n Chewy, distributed by 
Ingles Markets, Inc., Asheville, NC
F-365-9 Formulation 0220 under the following labels:
a) Fry's Chocolate Chip Soft'n Chewy Cookies, distributed by
Fry's Food and Drug Stores of Arizona, Phoenix, AZ
b) Marsh Chocolate Chip Soft'n Chewy Cookies, distributed by
Marsh Supermarkets, LLC, Indianapolis, IN
c) Merico Chocolate Chip Cookies Soft'n Chewy; responsible firm 
on the label is The Earthgrains Company, St. Louis, MO
d) Hy-Vee Chocolate Chip Cookies, distributed by Hy-Vee, Inc., 
West Des Moines, IA
e) Kroger Chocolate Chip Cookies, distributed by The Kroger
Co.,Cincinnati, OH
f) Great Value Chocolate Chip Cookies Spoonable Cookie Dough, 
marketed by Wal-Mart Stores Inc., Bentonville, AR
F-366-9 Formulation 0203 under the following label:
a) Weis Quality Soft'N Chewy Classic Cookies Chocolate Chip
Cookies with Pecans Spoonable Cookie Dough, packed for Weis
Markets, Inc., Sunbury,PA
CODE
All product with an expiration code of May 24, 1999, or earlier.
MANUFACTURER
Earthgrains Refrigerated Dough Products, Inc., Carrollton, Texas.
RECALLED BY
Earthgrains Refrigerated Dough Products, Inc., St. Louis, 
Missouri, by letter faxed on February 4, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
167,554 12-chub (tube) cases were distributed.
REASON
Product contains undeclared dairy products.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS 
III
________
PRODUCT
Primo(r), Heinz and Egg Beaters brands pasta products
a) Primo Orzo USA, Material # 5590030114; 
b) Primo Acini Di Pepe USA, Material # 5590030115;
c) Primo Scoobie-Do USA, Material # 559003145;
d) Primo Shells Large USA, Material #55930126; 
e) Primo Stelline USA, Material # 5590030113;
f) Primo Gnocchi USA, Material# 5590030123;
g) Primo Wagon Wheels USA, Material # 559003138; 
h) Primo Pepe Bucato USA, Material # 5590090111;
i) Heinz Acini Di Pepe, Material# 5590000902;
j) Egg Beaters Wide Noodles, Material #5590031500;
k) Egg Beaters Extra Wide Noodles, Material #5590031501.
Recall #F-351/361-9 
CODE
Lot numbers: a) 0265, 0266, 0304; b) 0188, 0265, 0305, 0306
c) 0149, 0202, 0307; d) 0162, 0277, 0278; e) 0182
f) 0240, 0241; g) 0190, 0191; h) 0264, 0306, 0307
i) Codes: N/A; j) Codes: N/A; k) 0153, 0154.
MANUFACTURER
Nabisco, Toronto, Ontario, Canada.
RECALLED BY
Nabisco, Inc., Parsippany, New Jersey, by letter faxed on 
November 27, 1998, followed by telephone November 28-30, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
a) 315 cases; b) 1,016 cases; c) 478 cases; d) 684 cases; e) 114 
cases; f) 484 cases; g) 360 cases; h) 40 cases; i) 141 cases; j) 
0 cases; k) 36 cases were distributed.
REASON
Products are contaminated with non-food grade gear oil which 
imparted an "off flavor" to the products rendering them unfit for 
food.
________
PRODUCT
Bon Secour brand Stuffed Jalapeno Peppers, packed 3 pounds per 
box and 6 boxes per cardboard carton.  Recall #F-368-9.
CODE
All codes on the market which do not list whole eggs as an 
ingredient.
MANUFACTURER
Johnson Sea Products, Inc., Coden, Alabama.
RECALLED BY
Manufacturer, by telephone March 25, 1999, followed by letter on 
April 1, 1999.  Firm-initiated field correction (labeling) 
ongoing.
DISTRIBUTION
Alabama.
QUANTITY
39 cases were distributed; firm estimated that very little 
product remained on market at time of recall initiation.
REASON
Product's label did not declare the ingredients whole eggs, 
(however a second egg ingredient yolk was listed on the label.)

RECALLS AND FIELD CORRECTIONS:  DRUGS 
-- CLASS II
________
PRODUCT
Chorionic Gonadotropin for Injection, USP, Lyophilized, 5,000 USP 
units, in 10 mL sterile multiple dose vials, under the Eveready, 
Steris, and Serono labels. NDC Nos.: 54548-125-10, 0402-0125-10, 
44087-8005-3.  Recall #D-199-9.
CODE
Lot #96C760 EXP 3/99.
MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY
Manufacturer, by letter dated February 15, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
15,330 vials were distributed.
REASON
Mislabeling - Product was labeled with incorrect expiration date- 
extended by one year.
________
PRODUCT
Chorionic Gonadotropin for Injection, USP (human), Lyophilized, 
10,000 USP Units, in 10 mL sterile multiple dose vials, Rx, under 
the following labels: Steris, Serono, and Schein.
NDC #0402-0126-10, 44087-8010-3, 0364-6706-54.
Recall #D-200-9.
CODE
Lot numbers:  97H730 and 98B550.
MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY
Manufacturer, by letter dated February 15, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide, Puerto Rico, Haiti, Trinidad.
QUANTITY
33,675 vials were distributed.
REASON
Product was compounded at lower potency than required by NDA 
and/or product was found to have atypical rejection level for 
visual particulates.
________
PRODUCT
a) Chorionic Gonadotropin For Injection, USP (Human), 
in 10 mL multiple dose vial, packaged with diluent, 5,000 USP 
Units, under the Eveready label;
b) Chorionic Gonadotropin For Injection, USP (Human), in 10 mL 
multiple dose vial, packaged with diluent, 10,000 USP units, 
under the following labels:  Steris, Serono, Zenith, 
c) Vecuronium Bromide For Injection, USP, 10 mg, in 10 mL vial, 
packaged with diluent, under the VHA Plus and Marsam labels.  
Recall D-201/203-9.

CODE
Lot Numbers     NDC Numbers 
a) 97L910      57548-125-10
b) 97K710      0402-0126-10
   97J410      44087-8010-3
   97J510      0182-1165-63
c) 97K950      0209-9141-96
   97L550      0209-9141-26.
MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY
Manufacturer, by letters dated February 14 and 23, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
a) 996 vials; b) 23,351 vials; c) 77,099 vials were distributed.
REASON
Diluent sold with product was found to contain "white fibers".
________
PRODUCT
Indomethacin Extended-Release Capsules, USP, Indochron  Capsules, 
75 mg, in 60 and 100 unit bottles, a prescription non-steroidal, 
anti-inflammatory drug used in the treatment of rheumatoid 
arthritis, ankylosing spondylitis and osteoarthritis, under the 
following labels:
Inwood NDC 0258-3607-06 (60s) and NDC 0258-3607-01 (100s)
Teva Pharmaceuticals USA NDC: 0093-0628-06
United Research Laboratories (URL), 60s  NDC: 0677-1197-06
Schein Pharmaceutical, 100s NDC: 0364-2211-01
Major Pharmaceuticals, 60s  NDC: 0904-1178-52, 
100s NDC: 0904-1178-60
Brightstone Pharma, 60s NDC: 62939-7012-7, 
100s NDC: 62939-7012-1
Zenith Goldline Pharmaceuticals,(Goldline Labs)
60s  NDC: 0182-1469-26, 100s NDC: 0182-1469-01
Qualitest Products,  60s  NDC: 0603-4070-20
100s NDC: 0603-4070-21
Geneva Pharmaceuticals, 60s NDC: 0781-2153-60.
Recall #D-205-9.
CODE
All lot numbers remaining in expiry: Lot numbers (expiration 
date): 
8A029 (3/1999), 8A031 (4/1999), 8A032 (4/1999), 8B028
(4/1999), 8A033 (6/1999), 8A034 (6/1999), 8B029 (6/1999),
8D004 (7/1999), 8D005 (7/1999), 8D006 (8/1999), 8D007
(8/1999), 8E027 (10/1999), 8E028 (10/1999), 8E029 (10/1999),
8E030 (10/1999), 8G049 (12/1999), 8G050 (12/1999), 8G051
(12/1999), 8G052 (12/1999), 8G053 (12/1999), 8G054 (1/2000),
8G055 (1/2000), 8J080 (1/2000), 8J081 (1/2000), 8J082
(2/2000), 8J084 (2/2000), 8J085 (2/2000), 8K030 (2/2000),
8K031 (2/2000), 8K032 (3/2000), 8K033 (3/2000), 8K034 (3/2000) 
and 8M022 (4/2000). 
MANUFACTURER
Inwood Laboratories, Inc., Inwood, New York.
RECALLED BY
Manufacturer, by letters dated March 30, 1999, and April 
6, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
197,328 60-count bottles and 205,580 100-count bottles were 
distributed; firm estimated that 60,000 bottles (60s) and 62,000 
bottles (100s) remained on market at time of recall initiation.
REASON
Dissolution failure (at stability testing).
________
PRODUCT
Compressed Medical Oxygen, U.S.P. Rx, in size D, E, M6, BB, M4, 
and H cylinders.  Recall #D-207-9.
CODE
Lot numbers (Batches): 
0316 (02,01) 
0315 (03,02,01) 
0312 (06,03) 
0311 (04,03,02,01,) 
0309 (06,05,04,03,02,01) 
0308 (02,01) 
0305 (06,05,04,03,02,01) 
0304 (07,06,05,04,03,02,01) 
0303 (01) 
0302 (05,04,03,02,01) 
0301 (05,04,03,02,01) 
0226 (04,03,02,01) 
0225 (03,02,01)
0224 (03).
MANUFACTURER
Professional Respiratory Services, Owings Mills, Maryland.
RECALLED BY
Manufacturer, by visit.   Firm-initiated recall ongoing.
DISTRIBUTION
Maryland.
QUANTITY
605 cylinders were distributed.
REASON
Current good manufacturing practice deviations including but not 
limited to failure to perform identity and potency testing prior 
to distribution.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- 
CLASS III
________
PRODUCT
Hydrocortone Phosphate Injection (Hydrocortisone Sodium Phosphate 
USP Injection), 50 mg per ml, Rx packaged in 2-ml single dose 
vials.  Recall #D-204-9.
CODE
Lot numbers 0037H, 0693H, 0920E, and 0944D.  All lots expire 
March 2001.
MANUFACTURER
Merck Manufacturing Division, Division of Merck and Company, 
Inc., West Point, Pennsylvania.
RECALLED BY
Manufacturer, by letter dated February 16, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
29,276 vials were distributed.
REASON
pH results in stability testing lower than specification 
________
PRODUCT
Duphalac (Lactulose Solution, USP), 20 g/30mL, Rx in unit dose 
cups.  Recall #D-206-9.
CODE
Lot #89901.
MANUFACTURER
Solvay Pharmaceuticals, Inc., Marietta, Georgia.
RECALLED BY
Manufacturer, by letter on April 8, 1999.  Firm-initiated 
recall ongoing.

DISTRIBUTION
Nationwide.
QUANTITY
2,088 units were distributed.
REASON
Mislabeling - Product bears generic name Lactose 
Solution, USP, rather than Lactulose Solution, USP and is 
incorrectly labeled to contain benzoic acid.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS 
II
________
PRODUCT
Red Blood Cells.  Recall #B-709-9.
CODE
Unit #21 Q88950.
MANUFACTURER
American Red Cross, Medford, Oregon.
RECALLED BY
American Red Cross, Portland, Oregon, by letter dated September 
24, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Oklahoma and Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to 
an area designated as endemic for malaria.
________
PRODUCT
Red Blood Cells.  Recall #B-710-9.
CODE
Unit #21KJ01911.
MANUFACTURER
American Red Cross, Portland, Oregon.
RECALLED BY
Manufacturer, by letters dated November 12, 1998, and December 2 
and 23, 1998.  Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to 
an area designated as endemic for malaria.
________
PRODUCT
a) Whole Blood; b) Red Blood Cells.  Recall #B-714/715-9.
CODE
Unit Numbers: a) 12LC06165; b) 12FS53748.
MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY
Manufacturer, by letter dated July 9, 1996.  Firm-initiated 
recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
1 unit  of each component was distributed.
REASON
Blood products tested non-reactive for the antibody to the 
Hepatitis B core antigen (anti-HBc), but were collected from a 
donor who was previously repeatedly reactive for anti-HBc on two 
separate donations.
________
PRODUCT
Red Blood Cells.  Recall #B-716-9.
CODE
Unit numbers:  12X30740 and 12X43888.
MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY
Manufacturer, by letter dated November 14, 1995.  Firm-initiated 
recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
2 units were distributed.
REASON
Blood products tested non-reactive for the antibody to the 
Hepatitis B core antigen (anti-HBc), but were collected from a 
donor who was previously repeatedly reactive for anti-HBc on two 
separate donations.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-717/718-9.
CODE
Unit #12V70582.
MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY
Manufacturer, by telephone and letter on June 19, 1996.  Firm-
initiated recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products tested non-reactive for the antibody to the 
Hepatitis B core antigen (anti-HBc), but were collected from a 
donor who was previously repeatedly reactive for anti-HBc on two 
separate donations.
________
PRODUCT
Platelets, Pheresis. Recall #B-722-9.
CODE
Unit numbers: 23137-3835-01 and 23137-3835-02.
MANUFACTURER
United Blood Services, Billings, Montana.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated 
October 22, 1998, and December 9, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
Montana.
QUANTITY
2 units were distributed.
REASON
Blood products had unacceptable platelet counts.
________
PRODUCT
Red Blood Cells.  Recall #B-726-9.
CODE
Unit #12X50059.
MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY
Manufacturer, by telephone on November 17, 1995.  Firm-initiated 
recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose hemoglobin check 
was marked as unsatisfactory.
________
PRODUCT
Platelets.  Recall #B-728-9.
CODE
36Y59102, 36Y59104, 36Y59105, 36Y59106, 36Y59107, 	36Y59110, 
36Y59111, 36Y59112, 36Y59117, 36Y59120, 36Y59124, 36Y59127, 
36Y59129, 36Y59130, 36Y59131, 36Y59132, 36Y59134, 36Y59135, 
36Y59136, 36Y59137.
MANUFACTURER
American Red Cross Blood Services, Columbia, South Carolina.
RECALLED BY
Manufacturer, by letter on June 8 or 9, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Georgia and South Carolina.
QUANTITY
20 units were distributed.
REASON
Blood products were manufactured from whole blood that was 
shipped at undocumented temperatures.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS 
III
________
PRODUCT
Red Blood Cells.  Recall #B-707-9.
CODE
Unit #16LS44645.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by telephone and letter on March 9, 1999.
Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Platelets, Pheresis.  Recall #B-713-9.
CODE
Unit numbers: 28LX05206, 28LX05207, 28LX05209, 28LX05213, 
28LX05214.
MANUFACTURER
American Red Cross Blood Services, Charleston, South Carolina.
RECALLED BY
American Red Cross Blood Services, Savannah, Georgia, by letter 
on both February 11 and 17, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
South Carolina.
QUANTITY
5 units were distributed.
REASON
Unlicensed blood products were distributed in interstate 
commerce.
________
PRODUCT
Platelets.  Recall #B-723-9.
CODE
Unit #65142.
MANUFACTURER
Lane Memorial Blood Bank, Eugene, Oregon.
RECALLED BY
Manufacturer, by telephone on August 4, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Oregon.
QUANTITY
1 unit was distributed.
REASON
Blood product had an extended rest time.
________
PRODUCT
Red Blood Cells, Leukocytes Reduced.  Recall #B-724-9.
CODE
Unit #03GH29742.
MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY
Manufacturer, by telephone on September 11, 1998, and by letter 
dated October 6, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Georgia.
QUANTITY
1 unit was distributed.
REASON
Blood product was leukodepleted greater than five days after 
collection.
________
PRODUCT
Red Blood Cells, Leukocytes Reduced.  Recall #B-725-9.
CODE
Unit numbers: 03E11798, 03FL76028, 03FR36459, 03GK39264, 
03LM77143.
MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY
Manufacturer, by letter dated September 17, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Georgia.
QUANTITY
1 unit was distributed.
REASON
Blood products were leukodepleted greater than five days after 
collection.
________
PRODUCT
Red Blood Cells.  Recall #B-727-9.
CODE
Unit #21KJ10551.
MANUFACTURER
American Red Cross, Portland, Oregon.
RECALLED BY
Manufacturer, by telephone on November 23, 1998, and by letter 
dated December 2, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Oregon.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.

RECALLS AND FIELD CORRECTIONS:  
DEVICES -- CLASS II
________
PRODUCT
All Datalink Management System Software Versions 4.1, 4.2, and 
4.3 , Part #464800, a data processing module for clinical use.  
Recall #Z-829-9.
CODE
The software is uncoded.  All Datalink software is being 
recalled.
MANUFACTURER
Beckman Coulter, Inc., Brea, California.
RECALLED BY
Manufacturer, by letter on December 10, 1998.  Firm-initiated 
field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
248 units were distributed.
REASON
The devices may allow the test results from an associated 
clinical instrument to be placed under an incorrect sample ID.
________
PRODUCT
Vitros ECi Immunodiagnostic System, an automated continuous 
random access immunoassay analyzer, Catalog No. 8633893.
Recall #Z-830-9.
CODE
All Serial Numbers up to 30000861 except 30000641, 30000775, 
30000838, and 30000851.
MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, New York.
RECALLED BY
Manufacturer, by letters dated February 19 and 25, 1999.  Firm-
initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
698 units were distributed.
REASON
Autodilution pump does not consistently dispense the expected 
amount of diluent at settings involving 180 or 190 uL dilution 
volumes.
________
PRODUCT
Shiley "Tracheosoft" Extended Length Disposable Cannula 
Tracheostomy Tubes, indicated for use in providing tracheal 
access for airway management:
a) Extended Length Cuffed Tracheostomy Tube, Catalog No. XLDT and 
XLTP;
b) Extended Length Cuffless Tracheostomy Tube, Catalog No. XCSD 
and XCSP;
c) Extended Length Disposable Inner Cannula, Catalog No. XIC.  
Recall #Z-833/835-9.
CODE
All Sizes and Lots.
MANUFACTURER
Mallinckrodt Medical, Inc., County Westmeath, Ireland.
RECALLED BY
Mallinckrodt, Inc., Irvine, California, by telephone on February 
20, 1999, followed by letter on February 22, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
2,043 units trach tubes and 12,750 units inner cannulae were 
distributed.
REASON
Conditions such as head base and flange may separate and 
disconnect from the outer cannula tube or the extended length 
disposable inner cannula tubing may separate from the connector 
during use which could result in a loss of airway.
________
PRODUCT
Discovery and Meridian Multiprogrammable Pacemakers, intended for 
use in patients who are symptomatic due to atrial and ventricular 
bradyarrhythmias:
a) Discovery SR Multiprogrammable Pacemakers, Model Nos. 1174 and 
1175;
b) Discovery DR Multiprogrammable Pacemakers, Model Nos. 1273, 
1274, and 1275;
c) Meridian SSI Multiprogrammable Pacemakers, Model No. 476;
d) Meridian DDD Multiprogrammable Pacemakers, Model No. 976;
e) Meridian SR Multiprogrammable Pacemakers, Model No. 1176;
f) Meridian DR Multiprogrammable Pacemakers, Model No. 1276. 
Recall #Z-836/841-9.
CODE
Serial Numbers:
Model 1174:
100198-100213, 100220-100224, 100226-100238, 100240-100243, 
100245, 100246, 100248-100275, 100277, 100278, 100280-100289, 
100295, 100329, 100334-100336, 100346, 100367, 100372-100374, 
100404, 100405, 100445, 100512, 100523, 100524, 100532, 100555, 
100562, 100564, 100592, 100593, 100734, 100752, 100753, 101165-
101167, 101169, 102320, 102321, 102336-102341, 102343-102349, 
102358-102368, 102370, 102376-102383, 102416, 102417, 102429-
102440, 102447, 
102448, 102450, 102452-102454, 102456, 102460-102466, 102470-
102475, 102477-102488, 102497, 102498, 102500-102524, 102526, 
102528-102609, 102630-102636, 102638-102667, 102669-102674, 
102676-102780, 102783-102801, 102804, 102805, 102809-102813, 
102815-102827, 102829-102832, 102834-102853, 
102855-102876, 102878-102939, 102941, 102942, 102944-102947, 
102949-103010, 103012-103019, 102021-103028, 103030, 103031, 
103036-103065, 103067-103094, 103096-103149, 103151-103260, 
103262-103265, 103267-103269, 103272-103288, 103290, 103292-
103306, 103308-103318, 103320-103322, 103324-103359, 
103361-103392, 103396-103407, 103409-103421, 103423-103425, 
103427-103442, 103444-103521, 103523-103526, 103529-103569, 
103571-103580, 103582-103599, 103601-103608, 103610-103655, 
103657-103672, 103674-103679, 103681-103684, 103686-103695, 
103700-103709, 103717, 103719-103731, 103733-103746, 103748, 
103749, 103751, 103753-103755, 103757-103767, 103769, 103773, 
103778, 103779, 103781-103783, 103785-103787, 103789-103846, 
103848-103889, 103891-103918, 
103920-103927, 103930-103936, 103938, 103939, 103942, 103943, 
103945, 103947, 103949-103951, 103954-103979, 103981-103991, 
193996, 103997, 103999, 104000, 104002, 104006-104009, 104020-
104038, 104040-104058, 104060-104062, 
104066-104086, 104089-104092, 104095-104098, 104100-104117, 
104119-104124, 104126-104134, 104140, 104142-104149, 104151-
104163, 104165-104167, 104169-104179, 104185-104198, 104202-
104205, 104207-104235, 104237-104253, 104255, 104256, 104270, 
104271, 103273-104285, 104287-104311, 104313-104321, 
104323, 104324, 104326, 103329-104334, 104347, 104248, 104354-
104358, 104365-104371, 104380, 104389, 104399-104402, 104405, 
104406, 104408, 104409, 104415-104418, 104425, 104437-104442, 
104450-104454, 104476-104479, 104481, 
104485, 104488, 104508, 104509, 104513, 104558, 104577, 104578, 
104589, 104609, 104652, 104838, 104839, 104929, 104961, 105001, 
105002, 105059, 105239, 105288, 105998, and 105999
Model 1175:
200016-200025, 200136, 200137, 200146-200152, 200156-200159, 
200162-200165, 200176, 200178-200185, 200187-200191, 
200193-200195, 200198-200205, 200212, 200214, 200215, 200223, 
200225, 200236-200240, 200259, 200260, 200279, 200280, 200310, 
200391, 200392, 200401, and 200402
Model 1273:
200215-200219, 300142-300155, 300157, 300160-300169,
300173-300176, 300178, 300180-300198, 300201, 300204-300209, 
300221-300227, 300231, 300238, 300239, 300266-300269, 300279, 
300335, 300363, 300516, 300517, 300519, 300582, 300583, 301436-
301438, 301548-301550, 301640, 301658, 301678, 301688-301690, 
303102, 304739, 304791-304795, 304812-304814, 304816-304819, 
304821-304823, 304825-304839, 304841-304853, 304855, 304856, 
304858-304890, 304893-304899, 
305300-305331, 305333, 305335, 305337-305349, 305351-305354, 
305356-305361, 305363-305388, 305390-305424, 305431-305445, 
305451-305460, 305466-305475, 305478-305486, 305494-305500, 
305502, 305504-305510, 305514-305520, 305523-305529,
305531-305550, 305555-305570, 305574-305648, 305650-305710, 
305721-305724, 305726, 305732-305740, 305744, 305745, 305747-
305769, 305771-305789, 305791-305795, 305797,
305800-305818, 305821-305837, 305840, 305842-305872, 305876-
305880, 305885-305891, 305894, 305896-305901, 305907, 
305909-305911, 305913, 305915-305945, 305947-305965, 
305967-305978, 305987-305995, 306001-306007, 306009-306012, 
306014, 306015, 306017-306020, 306022-306028, 306030-306053, 
306055-306069, 306071-306088, 306091-306095, 306098-306105, 
306108-306115, 306117, 306119-306124, 306126-306147, 
306149-306168, 306171-306179, 306181-306196, 306200-306250, 
306253-306267, 306269-306279, 306281-306311, 306313-306317, 
306321-306327, 306329-306339, 306341-306351, 306353-306371, 
306373-306376, 306378-306406, 306408, 306409, 306411-306434, 
306436-306459, 306451-306472, 306475, 306477-306552, 
306554-306620, 306626-306636, 306641-306645, 306651-306661, 
306670-306676, 306681-306688, 306701-306718, 306721-306730, 
306739-306752, 306760, 306765-306780, 306791-306797, 306818, 
306839, 306840, 306848, 306861, 306856-306870, 306889, 306891-
306894, 306896, 306897, 306899, 306907, 306927, 
306931, 306932, 306941-306947, 306980, 306983, 306999, 307000, 
307178, 307179, 307189, 307190, 307197, 307209, 307210, 307219, 
307220, 307231, 307259, 307260, 307269, 307360, 307498, 307528-
307530, 307533, 307535, 
307567-307570, 307589, 305590, 307607, 307608, 307620, 307631-
307637, 307645, 307651, 307652, 307654-307657, 307690, 307695-
307698, 307758-307760, 307780, 307846, 307857, 307859, 307860-
307862, 307864-307866, 307868, 307869, 307880, 307887-307892, 
307895, 307897-307900, 307909, 307910, 307919, 307920, 307961-
307964, 308039, 
308040, 308048-308050, 308068-308070, 308079, 308080, 308091, 
308092, 308097, 308099, 308109, 308110, 
308241-308244, 308249, 308250, 308259, 308260, 308346, 308369, 
308370, 308377-308388, 308408, 308409,
308417-301420, 308429, 308430, 308449, 308450,
308474-308478, 308539, 308571, 308572, 308609, 308610, 308800, 
308841-308843, and 309041 
Model 1274:
400195-400198, 400200-400211, 400213-400237, 400239-400251, 
400253-400262, 400264-400292, 400302-400304, 400320, 400321, 
400505, 400542-400544, 400633, 400773, 400774, 400811, 400813, 
401363, 401364, 401382, 401401-401403, 401842, 
401853, 402552, 402553, 402562, 402885, 402950,
403171-403180, 403182-403190, 403192-403196, 403211-403218, 
403221-403234, 403245-403252, 403254-403264, 403266-403273, 
403275-403278, 403280, 403284-403321, 403323-403325, 403329, 
403330, 403361-403364, 403366-403375, 403377, 403379-403386, 
403391-403394, 403396,403401-403414, 403416-403458, 403460-
403539, 403541-403546, 403551-403560, 403562, 403563, 403565-
403571, 403574-403587, 403589-403613, 403615-403618, 403625-
403649, 403651-403654, 403657, 403659-403683, 
403685-403722, 403726-403743, 403745-403836, 403838-403869, 
403871-403886, 403891-403896, 403898, 403899,
4030901-403908, 403912-403916, 403918-403923, 403925-403965, 
403967-403970, 403972-403977, 403979-403987, 403989-404012, 
404014-404046, 404048, 404049, 404051-404077, 404079-404089, 
404091-404110, 404112-404116, 404119, 404121-404150, 404152, 
404154-404164, 404166-404171, 404174-404222, 404224-404226, 
404228-404265, 404272, 404273, 404277-404280, 404282, 404284-
404353, 404355-404377, 404379-404384, 404386-404392, 
404394-404425, 404431-404448, 404450-404460, 404463-404470, 
404473, 404474, 404476, 404478, 404481-404488, 
404491-404496, 404501-404507, 404511-404516, 404518-404520, 
404527-404537, 404539-404545, 404548-404561, 404563-404581, 
404584-404592, 404601-404605, 404612-404617, 404620, 404621, 
404625-404629, 404631-404650, 404653-404656, 404658-404665, 
404671-404680, 404682, 404684-404695, 404697-404707, 404711-
404717, 404720, 404721, 404723-404736, 404741-404769, 404771-
404773, 404775-404777, 404779-404785, 404792-404817, 
404819-404875, 404877, 404878, 404880-404889, 404891-404897, 
404899-404908, 404912, 404913, 404915-404920, 404933-404940, 
404944-404970, 404974-404978, 404980, 404981, 404986-404991, 
405010, 405011, 405021-405030, 405037-405040, 405049, 405051-
405054, 405114-405118, 405121, 405160, 405180, 405183, 405192, 
405201, 405252-405258, 405297-405302, 405321-405323, 405325, 
405327-405329, 405381, 405382, 405391-405400, 405410, 405417, 
405431-405442, 405462-405464, 
405470, 405477-405479, 405481, 405482, 405507-405510, 405522, 
405523, 405531-405537, 405549, 405561, 405563, 405566, 405579, 
405582, 405691-405693, 405749, 405750, 405760, 405821-405825, 
405845, 405848-405850, 405859, 405860, 405879, 405880, 405898-
405900, 405930, 405988, 405989, 406006, 406007, 406009, 406010, 
406019, 406099, 406100, 406168, 406170, 406271-406276, 406303, 
406304, 
406352, 406719, 406720, 407039, 407040, and 407049
Model 1275:
500016, 500017, 500019, 500020, 500028, 500030,
500166-500171, and 500173-500185
Meridian Models:
Model 476:
100151, 100159, 100162-100200, 100204-100218, 100220-100240, 
100248-100258, 100259, 100260, 100281-100284, 100300, 100351-
100354, 101254, 101255, 101265, 101267, 
101268-101282, 101284-101291, 101304, 101311-101323, 
01326-101337, 101340-101352, 101354-101356, 101358-101364, 
101386-101410, 101412-101438, 101440, 101441, 101443-101489, 
101491, 101493-101509, 101513-101518, 101520, 101523-101562, 
101564-101570, 101572, 101574-101593, 101595-101607, 
101616-101673, 101675-101731, 101733, 101736-101739, 101741, 
101743, 101746-101754, 101756-101774, 101776-101790, 
101792-101794, 101796-101800,
101802-101811, 101816-101846, 101848-101851, 101854, 101856, 
101865, 101867-101909, 101916-101925, 101953, 101954, 101958, 
101962-101965, 101971-101975, 102004, 102005, 102032, 102035, 
102045, 102074, 102075, 102102, 102105, 102246, 102255, 102275, 
102318, 102321, 102322, 102325, and 102326
Model 976:
200101-200110, 200119-200150, 200152-200159, 200161-200167, 
200169, 200172-200186, 200188-200194, 200203-200211, 200213-
200220, 200222-200227, 200242-200245, 200459-200462, 200464, 
200465, 201035-201038, 201055, 201058-201064, 201066, 201073-
201082, 201087-201092, 201097-201101, 201105, 201106, 201113-
201127, 201129, 201131-201140, 201142-201156, 201158-201162, 
201164-201196, 201217-201233, 201235-201259, 201261-201272, 
201274-201279, 201282-201290, 201292-201314, 201316-201321, 
201323-201333, 201336-201366, 201368-201376, 201382-201423, 
201425-201429, 201431-201442, 201444, 201446-201465, 201467-
201503, 201507-201509, 201511-201516, 201520-201522, 201525-
201534, 201538-201549, 201551-201556, 201562-201571, 201573-
201585, 201587-201591, 201593-201606, 201610-201619, 201621-
201636, 201654-201656, 201664-201669, 201713, 201725, 201726, 
201729, 201745, 201754, 201756, 201764-201766, 201775, 201975-
201982, 201984, 202110-202113, 202116, and 202178
Model 1176:
300155-300164, 300175-300177, 300179-300182, 300184,
300187-300234, 300248, 300260-300263, 300270-300281, 300290, 
300294, 300956-300959, 300965-300969, 300980-301034, 301036, 
301040-301044, 301050, 301052-301054, 301056, 301081-301117, 
301119-301134, 301136-301159, 301161, 301162, 301165-301191, 
301193-301204, 301208-301214, 301217-301246, 301248-301272, 
301274-301307, 301309-301341, 301343-301355, 301357-301365, 
301367-301370, 301372-301376, 301380-301408, 301410-301418, 
301420-401437, 301439-301455, 301458-301479, 301487-301492, 
301495-301502, 301504, 301506-301562, 301564, 301569, 
301576-301580, 301582-301589, 301591-301614, 301616-301633, 
301648-301659, 301667-301669, 301679, 301690-301697,
301706-301709, 301730-301737, 301740-301743, 301757, 301759, 
301770-301772, 301780-301789, 301800-301804, 
301806, 301831, 301832, 301848, 301907, 301919, 301938, 301939, 
301979, 302047, 302048, 302050, 302075, 302076, 302078, 302079, 
302337-302339, and 302365
Model 1276:
400101-400107, 400109-400167, 400169-400178, 400180-400186, 
400188-400193, 400247, 400990, 400991, 401000-401004, 401006-
401009, 401015-401018, 401030-401033, 401035, 301037-401039, 
401057-401059, 401075-401095, 401097-401111, 401113-401129, 
401131-401145, 401150-401159, 401163-401199, 401230-401241, 
401246-401302, 401304-401338, 401340-401396, 401398-401470, 
401476, 401480-401485, 401487, 401489-401525, 401527, 401530-
401559, 401563-401565, 401568-401578, 401582-401592, 401594-
401609, 401615-401675, 401678, 401679, 401681-401683, 401687-
401704, 401706-401708, 401710-401715, 
401717-401721, 401723-401754, 401757-401760, 401763-401769, 
401771, 401772, 401775, 401780-401783, 401794-401797, 401799, 
401801, 401804, 401805, 401807-401811, 402058, 402059, 402065, 
402067, 402068, 402071, 402080, 402092, 
402093, 402094, 402097, 402098, 402310, 402330, 402331, and 
402341-402343.
MANUFACTURER
Guidant Corporation, Cardiac Pacemakers, St Paul, Minnesota.
RECALLED BY
Manufacturer, by letter dated March 29, 1999.  Firm-initiated 
field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
8,761 pacemakers were distributed.
REASON
The devices have a high current drain that prematurely depletes 
the battery power, resulting in no telemetry, pacing in backup 
mode, premature battery replacement, and no output conditions.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- 
CLASS II
________
PRODUCT
Sterile Penicillin G Benzathine and Penicillin G Procaine 
Suspension for Injection under the following labels:  Duo Pen 
(Agripharm); Ambi-Pen (Butler), and Sterile Penicillin G Procaine 
(Aspen).  Recall #V-048-9.
CODE
Lot #F8J008.
MANUFACTURER
Anthony Products, Irwindale, California.
RECALLED BY
Anthony Products Company, Arcadia, California, by telephone on 
March 9, 1999, and by letter on March 9, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Missouri, Ohio, Colorado.
QUANTITY
10,016 vials Agripharm brand DuoPen; 7,452 vials Butler Ambi-Pen
1,824 vials Aspen Sterile Penicillin G Procaine were distributed.
REASON
Product failed stability testing for potency.
________
PRODUCT
Veterinary Chorionic Gonadotropin for Injection, USP 10,000 units 
per sterile 10 ml multiple dose vial, for use in cows, 
distributed under the Steris label, and sold independently, and 
in a dual pack with bacteriostatic water for injection.
Recall #V-049-9.
CODE
Lot numbers: 97E320 and 97K710.
MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY
Manufacturer, by letter dated February 19, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
11,025 vials of lot 97E320 and 10,400 vials of lot 97K310 were 
distributed.
REASON
Silicon particulate matter in vials containing diluent 
bacteriostatic water for injection for lot 97K710.  Lot 97E320 is 
subpotent.
________
PRODUCT
Ruminant Animal Feed, custom formulated mixes in 50 pound bags 
and bulk sizes:
a) #8926 - Dairy Top Dress Pellets, bulk 
b) 4807 - Lamb Care 34 Conc, Pellets
c) 140000-JK  - 11058 Kaufman 35% Meal
d) 140000-BD 05286 Koch 38% Pellets
e) 3741 - Super 38 Dairy
f) 140000-EE 10128 U'Dean 35% Bunk meal
g) 140000-ZZ Lingle 33% WC, Pellets
h) 140000-AM 09098 Indorf Parlor 28% Meal
i) 140000-CJ 02179 Z-Ridge Diary Bunk, Pellets
j) 140024-AZ   Zutavern 25% Pellets
k) 4213 Beefcake 32 No Urea, bagged
l) 140000   10278 RUPP 27% Pellets
m) 140000ABX  - 02199 Rupp-Vue WC Bunk, Pellets
n) 140000-GM   02179 Hatfield, Meal
o) 140000-HN 11098 Catalpadale Hi, Meal
p) 140000-UU   01119 M. Hartzler 24% Pellets.
Recall #V-050/065-9.
CODE
All affected animal feeds, for dairy cattle and lamb, were 
produced on 3/8/99 and/or 3/9/99.
MANUFACTURER
National By-Products, Lynn Center, Illinois (meal and bone meal 
supplier).
RECALLED BY
Cargill, Inc., Wooster, Ohio, by telephone between March 9 and 
11, 1999.  Completed recall resulted from sample analysis and 
follow-up by the Ohio Department of Agriculture.
DISTRIBUTION
Ohio.
QUANTITY
275,413 pounds were distributed.
REASON
Animal feeds were inadvertently mixed with ruminant meat and bone 
meal in violation of 21 CFR 589.2000, instead of the pork meat 
and bone meal routinely used by the company.  
________
PRODUCT
Co-op 20% Prime Line F, bulk pelleted non-medicated finished feed 
for lactating dairy cattle, Item #243, tag code #032095-243.  
Recall #V-066-9.
CODE
Not coded.
MANUFACTURER
Tennessee Farmers Coop Feed Mill, Rockford, Tennessee.
RECALLED BY
Tennessee Farmers Coop, LaVergne, Tennessee, by visit on February 
15, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
84,000 pounds were distributed.
REASON
Cross contamination of a non-medicated lactating dairy cattle 
feed with a medicated beef cattle feed containing lasalocid.


END OF ENFORCEMENT REPORT FOR MAY 5, 1999.


####