FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.

July 9, 1997 97-28

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Popsicle brand Vanilla Flavored Ice Cream Sandwich, 3.5
fluid ounces, individually wrapped. Recall #F-487-7.
CODE Production codes: 348 6 SP1, shipper code 348-6
(manufactured on 12/13/96) 009 7 SP1, shipper code 009-7
(manufactured on 1/1/97) HG 041 97 2411 SP1&2, shipper code
041-7 (mfg. on 2/11/97). Individually wrapped sandwiches
bear the following code: Plant 24-0011.
MANUFACTURER Good Humor - Breyers Ice Cream (GH-B), Hagerstown,
Maryland.
RECALLED BY Good Humor - Breyers Ice Cream, Green Bay,
Wisconsin, by fax on April 18, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 279 cases (96 units per case) were distributed.
REASON Product contains undeclared peanuts and FD&C Yellow No.
6.

_______________
PRODUCT Breakfast Entrees: a) Western Style Omelet (Flavored
With Ham) with Sausage Links and Hashbrown Potatoes and
b) Blueberry Pancakes With Sausage Links And Syrup.
Recall #F-489/490-7.
CODE a) 0615D, Sept. 6, 1995, Sept. 20, 1995, and b) Sept. 26,
1995.
MANUFACTURER Buddy's Kitchen, Incorporated, Burnsville,
Minnesota.
RECALLED BY Manufacturer, by telephone on October 2, 1995,
then again on December 13, 1995. Firm-initiated
recall completed on January 23, 1996.
DISTRIBUTION Northwest Airlines.
QUANTITY Firm estimates none remains on the market.
REASON Product was contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Baked Lay's brand Original Potato Crisps, in 2-1/8
ounce bags. Recall #F-480-7.
CODE Manufacturing codes 415405 and 415205, Lot #03 June 97.
MANUFACTURER Frito-Lay, Inc., Frankfort, Indiana.
RECALLED BY Frito-Lay, Inc., Plano, Texas, by hand held
communication devices on May 14, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Michigan, Ohio, Minnesota, Missouri.
QUANTITY 8,400 bags were distributed.
REASON The product contains the undeclared dairy ingredients
dried whey and non fat dried milk. The product bears
an inappropriate identity statement.

_______________
PRODUCT BBQ Potato Chips and Fried Cheese Twists; a) BBQ Potato
Chips in bags labeled in part Albertsons Barbecue
Flavored Potato Chips Packed for Albertson's Inc.
Boise, Idaho 83726 in 8 ounce and 14 ounce packages
b) Fried Cheese Twists in bags labeled in part Albertsons
Fried Cheese Twists Packed for Albertson's, Inc. Boise,
Idaho 83726 in 12 ounce packages. Recall F-481/482-7.
CODE BBQ Potato Chip codes are identified with the following
pull dates: 11/11/96, 11/16/96, 11/24/96, 1/22/97,
1/27/97, 1/29/97, 3/26/97, 4/9/97, 4/27/97, 5/5/97,
5/22/97, 5/28/97, 6/3/97, 6/9/97, 6/10/97, 6/24/97,
7/1/97, 7/7/97
Fried Cheese Twist codes are identified with the following
date codes 8/3/96, 8/25/96, 9/24/96, 10/6/96, 10/3/96,
1/13/97, 1/16/97, 1/24/97, 2/2/97, 2/12/97, 3/6/97, 4/2/97,
6/2/97, 6/20/97, 7/3/97, 7/4/97, 7/17/97.
MANUFACTURER Nalley's Canada Limited, Delta, BC
-2-RECALLED BY Albertson's, Inc., Boise, Idaho, by fax on April
2, 1997. Firm-initiated recall complete.
DISTRIBUTION California, Nevada, Ohio, Washington state, Idaho.
QUANTITY (a) 3,064 cases (12 8-ounce bags per case), 4,209 cases
(12 14-ounce bags per case; b) 2,440 cases were
distributed.
REASON a) The BBQ Chips contain undeclared wheat flour and
hydrolyzed soy protein.
b) The Fried Cheese Twists contain undeclared FD&C Yellow
No. 5 and monosodium glutamate.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Cotton Club brand Ginger Ale packed in 12 fluid ounce
aluminum cans. Recall #F-486-7.
CODE Lot codes 6306 and 6345 for 2 liter bottles only and lot
code 6309 for 12 oz. cans and 2 liter bottles.
MANUFACTURER Cotton Club Bottling Company, Cuyahoga Heights,
Ohio.
RECALLED BY Manufacturer, by telephone on June 12, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Ohio.
QUANTITY 10,000 cases (240,000 12-ounce cans) and 7,500 cases
(60,000 2-liter bottles) were distributed.
REASON The product is unfit for food due to the presence of
yeast and mold.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT Pentothal (Thiopental Sodium for Injection, USP) Ready-to-Mix Syringe Kit, 500 mg 2.5% (25 mg/ml), used as an
anesthetic.
Recall #D-221-7.
CODE Kit Lot #26-652-DK.
MANUFACTURER Abbott Laboratories, Rocky Mount, North Carolina.
RECALLED BY Abbott Laboratories, Hospital Products Division,
Abbott Park, Illinois, by letter dated June 17,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 31,775 kits were distributed; firm estimated that 70
percent of the product remained on market at time of
recall initiation.
REASON Product is packaged in a kit that has a separate
expiration date exceeding that of the Pentothal
component expiration date.
-3-_______________
PRODUCT Clindamycin Phosphate Injection, USP, 150 mg/ml; an Rx
small volume parenteral semisynthetic antibiotic for IV
or IM administration, packaged in 2 ml, 4 ml, and 6 ml
single dose vials and 60 ml bulk vials. Recall #D-222-7.
CODE List 4050 (2 ml fliptop vial): lots 08-045-DK, 09-055-DK,
11-020-DK, 14-449-DK, 16-537-DK, 20-589-DK
List 4051 (4 ml fliptop vial): lots 07-143-DK, 08-529-DK,
08-541-DK, 08-650-DK, 09-119-DK, 10-537-DK, 12-472-DK,
13-233-DK, 13-258-DK, 15-073-DK, 15-267-DK, 16-606-DK,
18-613-DK, 18-533-DK, 19-223,DK, 20-453-DK, 20-676-DK,
21-188-DK, 22-451-DK, 22-682-DK, 25-023-DK, 26-350-DK
List 4052 (6 ml fliptop vial): lots 06-427-DK, 08-383-DK,
09-108-DK, 10-448-DK, 11-293-DK, 13-221-DK, 14-435-DK,
15-135-DK, 16-371-DK, 17-161-DK, 20-381-DK, 22-672-DK
List 4053 (2 ml ADD-Vantage vial): lots 15-245-DK,
21-166-DK, 27-276-DK
List 4054 (4 ml ADD-Vantage vial): lots 12-417-DK,
13-177-DK, 15-254-DK, 15-264-DK,
16-669-DK, 18-412-DK, 19-198-DK, 19-209-DK,
20-498-DK, 20-509-DK, 21-175-DK, 22-610-DK,
24-531-DK, 25-160-DK, 26-558-DK, 27-002-DK,
27-162-DK
List 4055 (6 ml ADD-Vantage vial): 12-427-DK, 13-164-DK,
17-016-DK, 19-220-DK, 20-521-DK, 21-184-DK, 22-600-DK,
25-024-DK, 28-588-DK
List 4197 (60 ml): 08-459-DK, 11-250-DK, 18-641-DK,
21-090-DK.
MANUFACTURER Abbott Laboratories, Rocky Mount, North Carolina.
RECALLED BY Abbott Laboratories, Hospital Products Division,
Abbott Park, Illinois, by letter dated June 20,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,262,319 vials were distributed; firm estimated that 5
percent of product remained on market at time recall
initiation.
REASON Bulk Clindamycin was recalled by Roussel Corporation
(parent firm of Biochimica Opos) due to AADA
(Abbreviated Antibiotic Drug Application) discrepancies
regarding manufacturing process.

-4-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-731-7.
CODE Unit #1968761.
MANUFACTURER Department of the Army, The Blood Bank Center,
U.S. Army Medical Department Activity, Fort Hood,
Texas.
RECALLED BY Manufacturer, by letter dated July 16, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who received
tattoos with 12 months of donation.

_______________
PRODUCT Platelets. Recall #B-789-7.
CODE Unit #13FS42856.
MANUFACTURER American Red Cross Blood Services, Detroit,
Michigan.
RECALLED BY Manufacturer, by telephone on November 27, 1996,
followed by letter dated December 18, 1996. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood Cells
that was reported as having clotted segments.

_______________
PRODUCT Red Blood Cells. Recall #B-925-7.
CODE Unit #24LE22526.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated April 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product had undergone atypical viral testing for
HBsAg, unit then tested into compliance with no
confirmatory test.

_______________
PRODUCT Recovered Plasma. Recall #B-943-7.
CODE Unit #21GJ69700.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated May 13, 1997. Firm-initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported a
history of cancer.

-5-_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c)
Recovered Plasma. Recall #B-967/969-7.
CODE Unit numbers: 11031-4696, 11027-7995; b) 11027-7995; c)
11031-4696.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated February 21, 1997, and April 28,
1997. Firm-initiated recall complete.
DISTRIBUTION New Mexico, Texas, Switzerland.
QUANTITY a) 2 units; b) 1 unit c) 1 unit was distributed.
REASON Blood products were collected from a donor who was
implicated in a post transfusion hepatitis case.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-970/971-7.
CODE Unit #24LH38576.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated May 8, 1996. Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had undergone atypical viral testing for
HBsAg, units then tested into compliance with no
confirmatory test.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-972/974-7.
CODE Unit #24GV38432.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated May 6 and 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had undergone atypical viral testing for
HBsAg, units then tested into compliance with no
confirmatory test.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-975/976-7.
CODE Unit numbers: 24LS16323, 24LQ09568, 24LJ18917, 24LQ12589,
24LJ20986, 24LK30429, 24LS20053, 24GV33296, 24LM20574,
24LZ08419, 24LE9558, 24GV24961, 24FO1626, 24LE28148,
24LH38010, 24LZ07087, 24LJ29530, 25LJ29626, 24LQ24678,
24GS15913, 24LS24561, 24GS15903, 24LH39760, 24LG31344.
MANUFACTURER American Red Cross, Louisville, Kentucky.
-6-RECALLED BY Manufacturer, by letters dated April 9, 19, 22,
24, 1996, and by letters dated April 8, 9, 17, 18,
1996 and May 6, 7, and 8, 1996. Firm-initiated
recall complete.
DISTRIBUTION Indiana, Kentucky, New York, Pennsylvania,
California, Switzerland.
QUANTITY 24 units of each component was distributed.
REASON Blood products had undergone atypical viral testing for
HBsAg, unit then tested into compliance with no
confirmatory test.

_______________
PRODUCT Red Blood Cells. Recall #B-977-7.
CODE Unit #19GM08233.
MANUFACTURER American Red Cross Blood Services, Nashville,
Tennessee.
RECALLED BY Manufacturer, by telephone on June 5, 1997. Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose spouse
has hepatitis B.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-978/979-7
CODE Unit numbers: 42FW38674, 42FX56606; b) 42FX56606.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated April 30, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY a) 2 units; b) 1 unit was distributed.
REASON Blood products were collected from a donor who traveled
to an area considered endemic for malaria.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-980/982-7.
CODE Unit #1446406.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letters dated May 14, 1997, and
June 11, 1997. Firm-initiated recall complete.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had been
previously deferred for high risk behavior.

-7-_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-983/984-7.
CODE Unit numbers: a) 50F42051, 50F38021, 50F45169; b) 50F42051
and 50F45169.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY Manufacturer, by letter dated March 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York, Michigan, Ohio.
QUANTITY a) 3 units; b) 2 units were distributed.
REASON Blood products were collected from a donor who traveled
to an area considered endemic for malaria.

_______________
PRODUCT Platelets. Recall #B-985-7.
CODE Unit #13FS45042.
MANUFACTURER American Red Cross Blood Services, Detroit,
Michigan.
RECALLED BY Manufacturer, by letter dated May 7, 1997. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood Cells
that was returned because of clotted segments.

_______________
PRODUCT Platelets. Recall #B-986-7.
CODE Unit #53GL82147.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated December 4, 1995.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole Blood
with an extended collection time.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-987/988-7.
CODE Unit numbers: a) 53GL61976, 53H14168, 53FN17719; b)
53H14168.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated March 27, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maryland and District of Columbia.
QUANTITY a) 3 units; b) 1 unit was distributed.

-8-REASON Blood products were collected from a donor who traveled
to an area considered endemic for malaria.

_______________
PRODUCT Platelets, Pheresis. Recall #B-989-7.
CODE Unit #40P51426.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on March 24, 1997,
followed by letter dated March 25, 1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for CMV, but was
collected from a donor who previously tested CMV
positive.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-990/991-7.
CODE Unit #24LC01724.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letters dated October 20, 1995,
and October 16, 1995. Firm-initiated recall
complete.
DISTRIBUTION Kentucky and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products which tested repeatedly reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-732/733-7.
CODE Unit numbers: a) 1971736 and 1969431; b) 1970342.
MANUFACTURER Department of the Army, The Blood Bank Center,
U.S. Army Medical Department Activity, Fort Hood,
Texas.
RECALLED BY Manufacturer, by letter dated July 16, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas and Florida.
QUANTITY a) 2 units; b) 1 unit was distributed.
REASON Blood products were collected from donors who received
tattoos within 12 months of donation.

_______________
PRODUCT Confide HIV Home Test Kit - Federal Express Mailers.
Recall #B-855-7.
-9-CODE None.
MANUFACTURER Direct Access Diagnostics (DAD), Bridgewater, New
Jersey.
RECALLED BY Manufacturer, by issuing revised instructions on
February 19, 1997, and by telephone beginning on
March 7, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 76,872 mailers were distributed.
REASON Federal Express mailer packages were incorrectly
attached to a competitor firm's packaged product and
distributed.

_______________
PRODUCT Thrombin - JMI Topical Thrombin, 5,000 U.S. Units and
1,000 U.S. Units.
Recall #B-922-7.
CODE Lot numbers: R114A77 (5000 US Units), R113A27, R113A28,
R113A30 (1,000 US Units)
MANUFACTURER GenTrac, Inc., subsidiary of Jones Medical
Industries, Inc., Middleton, Wisconsin.
RECALLED BY Manufacturer, by letter dated April 9, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,600 vials were distributed.
REASON Product failed six-month stability testing for its
labeled potency.

_______________
PRODUCT Red Blood Cells. Recall #B-966-7.
CODE Unit #32GF11029.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by telephone on October 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported a
post donation illness.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Vangator II Personal Transit Lift, Model #9684, an
electro-mechanical wheelchair lift for American-made,
full-size vans with side doors. Recall #Z-673-7.
CODE Various serial numbers.
MANUFACTURER Crow River Industries, Inc., Brooten, Minnesota.
RECALLED BY Crow River Industries, Inc., Minneapolis,
Minnesota, by letter on April 17, 1997. Firm-initiated recall ongoing.
-10-DISTRIBUTION Nationwide, Canada, Israel, Italy, Norway.
QUANTITY 413 lifts were distributed.
REASON Part failures allows: (1) the lift platform to free
fall from the stowed vertical position to the unstowed
horizontal position; and (2) the unfolded lift to drop
with the patient on it from the vehicle floor level to
the ground surface level.

_______________
PRODUCT Premium Multifire TA (Stapler):
a) Premium Multifire TA 30-V3 (stapler), Order Code 010315
b) Premium Multifire TA 60-3.5 (stapler), Order Code: 010317
c) Premium Multifire TA 60-4.8 (stapler), Order Code:
010319. Recall #Z-684/686-7.
CODE Lot numbers: a) N6E33, N6E283, N6F91, N6G37, N6H97, N6K55,
N6M132, N6M137, N6M232, N6M248, N6G189, N6J06;
b) N6E47, N6E68, N6E303, N6F88, N6F166, N6G88, N6G127,
N6H09, N6H84, N6H94, N6H138, N6J19, N6F68, N6J171, N6J217,
N6F160, N6K116, N6K186, N6K205, N6M172, N6M269, N7A53,
N6F226, N6J186
c) N6E125, N6F116, N6F178, N6G113, N6H22, N6J30, N6J35F,
N6J243, N6K145, N6K175, N6M188, N7A30.
MANUFACTURER United States Surgical Corporation, Norwalk,
Connecticut.
RECALLED BY Manufacturer, by letter dated April 17, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 41,180 units were distributed.
REASON The jaws of the devices may fail to open upon firing a
staple, which can result in tissue damage to the
patient.

_______________
PRODUCT Precision Medical Flowmeters, used to provide a metered
dose of oxygen to patients in the hospital environment:
a) Product No. 2MFA1008
b) Product No. 2MFA1008C
c) Product No. 2MFA1008PTO
d) Product No. D2MFA1008
e) Product No. D2MFA1008C
f) Product No. Y2MFA1008
g) Product No. Y2MFA1008C.
Recall #Z-698/704-7.
CODE Date codes from 395 to 397.
MANUFACTURER Precision Medical, Northampton, Pennsylvania.
RECALLED BY Manufacturer, by letter dated March 19, 1997.
Firm-initiated recall ongoing.
-11-DISTRIBUTION Nationwide.
QUANTITY Approximately 2,691 devices were distributed.
REASON The devices may catch on fire during use in high flow
situations (10LPM and greater) when mounted to hospital
Puritan-Bennett wall outlets.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT MaxiCide Plus Glutaraldehyde Sterilizing and
Disinfecting Solution, packaged in 1 gallon bottles.
Recall #Z-642-7.
CODE Lot #7B-0037.
MANUFACTURER Chemrite Industries, Inc., Lannon, Wisconsin.
RECALLED BY Cottrell, Ltd., Englewood, Colorado, by telephone
and letter dated May 2, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Indiana, Nevada, New York.
QUANTITY 500 cases (2,000 gallons) were distributed.
REASON Part of the subject lot was mislabeled as MaxiCide,
which contains 2.4% glutaraldehyde, rather than
MaxiCide Plus, which contains 3.4% glutaraldehyde.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III =========
_______________
PRODUCT Premix 313 PMB PAK 78Y (a medicated feed containing
roxarsone, lincomycin and monensin). Recall #V-040-7.
CODE Lot #090667 EXP 5/99, Drug Lot #AB560475.
MANUFACTURER Precision Microblenders, Inc., Ciales, Puerto
Rico.
RECALLED BY Manufacturer, by telephone on or about April
29, 1997. Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 200 pounds were distributed; firm estimates none
remain on the market.
REASON Roxarsone level was below the expected levels.

-12-

END OF ENFORCEMENT REPORT FOR JULY 9, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for