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.

March 24, 1999                                      99-12

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT
Allegro Cookies: a) Allegro Butter Cookies Filled with Eclair, in cartons containing 8 200-gram packages; b) Allegro Butter Cookies Filled with Chocolate, net weight 7 ounces (200 grams). Recall #F-227/228-9.

CODE
No manufacturing codes and no expiration dates. Products can be identified by UPC symbols as follows: a) 092719361831; b) 092719361817.

MANUFACTURER
Hagavia Wafer Products Ltd., Netivot, Israel.

RECALLED BY
Dangold, Inc., Flushing, New York, by letter on January 12, 1999, and by press release December 31, 1998, and January 8, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
New York, New Jersey, California, Massachusetts, Florida, Texas, Tennessee, North Carolina, Illinois, Michigan, Maryland, Pennsylvania.

QUANTITY
Approximately 736 cases (8 packages/case) were distributed with deficient label.

REASON
Product contains hazelnuts, but does not declare this ingredient in the statement of ingredients in the English language.

________
PRODUCT
SunBurst Bar-B-Que w/Slaw Sandwich, 3.25 ounces. Recall #F-229-9.

CODE
All products on the market at the time of the recall.

MANUFACTURER
SunBurst Foods, Inc., Goldsboro, North Carolina.

RECALLED BY
Manufacturer, by letter dated October 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
North Carolina, South Carolina, Virginia.

QUANTITY
Firm estimates none remains on the market.

REASON
Product contains undeclared eggs.

________
PRODUCT
Royal Baltic brand Smoked Shad, packaged in vacuum packed flexible plastic bags, or distributed as whole, unpackaged/unlabeled fish. Recall #F-240-9.

CODE
Lot #2710.

MANUFACTURER
Royal Baltic Ltd., Brooklyn, New York.

RECALLED BY
Manufacturer, by letter, telephone, and press release on November 9, 1998. Completed recall resulted from sample analysis and follow-up by the New York Department of Agriculture and Markets. See also FDA press statement dated November 13, 1998.

DISTRIBUTION
New York, California, Oregon, Washington state Illinois.

QUANTITY
471.8 pounds were distributed.

REASON
Product was contaminated with Listeria monocytogenes.

________
PRODUCT

Lindt Truffles and Gourmet Truffles:
a) Lindt Chocolate Truffles milk variety 
b) Lindt Chocolate Truffles dark variety
c) Lindt Chocolate Truffles white variety
d) Lindt Chocolate Truffles milk hazelnuts variety
e) Lindt Chocolate Truffles amaretto variety
f) Lindt Chocolate Truffles mint variety
g) Lindt Chocolate Truffles cinnamon variety
h) Lindt Chocolate Truffles orange variety
I) Lindt Gourmet Truffles milk/amaretto variety
j) Lindt Gourmet Truffles milk/orange variety
k) Lindt Gourmet Truffles dark/dark variety
l) Lindt Gourmet Truffles milk/milk variety
m) Lindt Gourmet Truffles white/dark variety
n) Lindt Gourmet Truffles dark/white variety.
Recall #F-241/254-9.

CODE
All product on the market which does not contain the statement "May contain traces of peanuts/nuts".

MANUFACTURER
Lindt & Sprungli (USA), Inc., Stratham, New Hampshire.

RECALLED BY
Manufacturer, by press release on January 7, 1999, by letter on January 7 and 8, 1999, and by E-mail on January 11, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Canada, Australia.

QUANTITY
Approximately 400,000 pounds.

REASON
Products may be contaminated with peanut residue.

________
PRODUCT
a) Nigiri Sushi, net weight 6 pounds; b) California Roll, (imitation crabmeat sushi), net weight 8 pounds. Recall #F-255/256-9.

CODE
a) All lot numbers beginning with 40; b) All lot numbers beginning with 10.

MANUFACTURER
Fifo Food Systems, Inc., Gardena, California.

RECALLED BY
Manufacturer, by fax on January 20, 1999. Firm-initiated recall complete.

DISTRIBUTION
California and Illinois.

QUANTITY
Undetermined.

REASON
Products contain undeclared eggs.

________
PRODUCT

Kedem brand Grape Juices in 650 ml, 1 liter, and 1.5 liter glass
bottles in the following flavors:
a) Kedem brand Naturel Blanc Grape Juice (French label),
with a white and orange label, labeled in part, "*** KEDEM ***
Naturel Blanc *** GRAPE JUICE *** JUS DE RAISIN *** PRODUCED BY
*** KEDEM FOOD PRODUCTS ***" in 650 ml, 1 liter, and 1.5 liter
glass bottles;
b) Kedem brand Gold Grape Juice (French label), with a brown
label containing black lettering, labeled in part, "*** KEDEM ***
Naturel *** BLANC *** GRAPE JUICE *** JUS DE RAISIN *** PRODUCED
BY *** KEDEM FOOD PRODUCTS ***" in 650 ml, 1 liter, and 1.5 liter
glass bottles;
c) Kedem brand Peach Grape Juice (French label), with a white and
cream colored label, labeled in part, "*** KEDEM *** Peach ***
GRAPE JUICE *** Jus de Peche *** PRODUCED BY KEDEM *** FOOD
PRODUCTS ***"in 650 ml, 1 liter, and 1.5 liter glass bottles;
d) Kedem brand Naturel Blush Rougir Grape Juice (French
label), with white and peach colored label, labeled in part, "***
KEDEM *** Naturel *** Blush *** ROUGIR *** GRAPE JUICE *** JUS DE
RAISIN *** PRODUCED BY *** KEDEM FOOD PRODUCTS ***"in 650 ml, 1
liter, and 1.5 liter glass bottles;
e) Concord Grape Juice
     i) Kedem brand in 650 ml, 1 liter, and 1.5 liter glass     
bottles with white and purple labels,(French label) labeled     
in part, "*** KEDEM *** Naturel Concord Rouge *** GRAPE JUICE ***
JUS DE RAISIN *** PRODUCED BY *** KEDEM FOOD PRODUCTS  ***"
     ii) Kedem brand in 650 ml, 1 liter, and 1.5 liter glass     
bottles with white and purple labels, (Spanish label) labeled in
part " *** KEDEM *** Hecho con ***  Uvas Concord  *** JUGO DE UVA
*** PRODUCTO EXPORTADO POR: *** Royal Wine  Co. ***" 
     iii) Season brand in 650 ml glass bottles labeled in part,   
"*** SEASON *** BRAND *** Grape Juice *** CONCORD *** Net   Wt.
22 Fl. Oz. (1 Pt. 6  Oz.) 650 ml *** DISTRIBUTED BY ***     
SEASON PRODUCTS CORP. *** IRVINGTON, N.J. 07111 *** PRODUCT OF
U.S.A. ***."  Recall F-258/262-9.

CODE
All product on the market failing to declare the presence of sulfites.

MANUFACTURER
Royal Wine Corporation, doing business as Kedem Food Products Company, Marlboro, New York (bulk juice).

RECALLED BY
Royal Wine Corporation, doing business as Kedem Food Products Company, Brooklyn, New York (bottler), by letter dated January 28, 1999. Firm-initiated field correction (relabeling) ongoing.

DISTRIBUTION
New Jersey, Canada, Mexico.

QUANTITY
Firm estimated that 20,000 cases (8 or 12 bottles per case) of the Kedem grape juices with the French labels; approximately 900 cases (8 or 12 bottles per case) of the Kedem Concord Grape Juice; approximately 210 cases (12 bottles per case) of the Season brand juice were distributed.

REASON
Products contain undeclared sulfites.

________
PRODUCT
Pusan Clam Meat Fishcake in individual 12.3 ounce vacuum-packaged packages, and in bulk. Recall #F-263-9.

CODE
Catalog #33650 10010 on each label.

MANUFACTURER
Doo Rae Trading Company, Fullerton, California.

RECALLED BY
Manufacturer, by telephone on January 8, 1999, and by press release on January 13 and 14, 1999. Firm-initiated recall complete.

DISTRIBUTION
California and New York.

QUANTITY
466 cases (50 units per case) and 5,553 bulk pounds were distributed.

REASON
Product contains undeclared egg whites and undeclared wheat gluten.

________
PRODUCT

The Egg Roll Castle Egg Rolls in shipping boxes containing 20
packaages consisting of 12 egg rolls each:
a) Vegetable Egg Roll (lumpia) 15 ounces, UPC 76241412340;
b) Seafood Vegetable Egg Roll (Lumpia) 15 ounces, 
UPC 76241443210;
c) Vegetable Egg Roll with Pork Flavor (Lumpia) 15 ounces,
UPC 76241426789; 
d) Vegetable Egg Roll with Beef Flavor (Lumpia) 15 ounces,
76241498650;
e) Vegetable Egg Roll with Chicken Flavor (Lumpia) 15 ounces, UPC
76241400568.  Recall #F-264/268-9.

CODE
All product on the market at the time of the recall.

MANUFACTURER
The Egg Roll Castle Company, San Diego, California.

RECALLED BY
Manufacturer, by letter on January 29, 1999, and press release on February 1, 1999. Firm-initiated recall ongoing.

DISTRIBUTION Nationwide.

QUANTITY
2,800 cases were distributed.

REASON
Product contains undeclared egg whites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________
PRODUCT
Breyers Big 1-1/2 Pints All Natural Ice Cream in 3 flavors: a) Vanilla; b) Vanilla-Chocolate-Strawberry; c) Butter Pecan. Recall #F-224/226-9.

CODE
Lot numbers: a) BF01999, BF03499, and BF03699; b) BF35098 and BF02099; c) BF34998, BF01999, and BF03499.

MANUFACTURER
Good Humor Breyers Ice Cream, Framingham, Massachusetts.

RECALLED BY
Good Humor Breyers Ice Cream, Green Bay, Wisconsin, by telephone on February 23, 1999, and by letter on February 24, 1999. Firm-initiated recall ongoing.

DISTRIBUTION Nationwide.

QUANTITY
36,780 pints were distributed.

REASON
Products may contain pieces of metal.

________
PRODUCT

Various sandwiches under the SunBurst label:
a) Shaved Ham & Cheese, 3.75 oz
b) Home Made Chicken Salad, 4.0 ounces
c) Roast Beef, 3.75 ounces
d) Turkey on Wheat, 3.5 ounces
e) Pimento Cheese Spread, 3.75 ounces
f) Ham & Turkey, 5.0 ounces
g) 1/4 lb. Bacon Cheeseburger, 5.0 ounces
h) Steak & Cheese Sub, 5.75 ounces
i) Breaded Chicken, 5.5 ounces
j) Deli Deluxe Turkey, Ham & Cheese Sub, 7.5 ounces.
Recall #F-230/239-9.

CODE
All products on the market at the time of recall.

MANUFACTURER
SunBurst Foods, Inc., Goldsboro, North Carolina.

RECALLED BY
Manufacturer, by letter dated October 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
South Carolina, North Carolina, Virginia.

QUANTITY
Firm estimates none remains on the market.

REASON
Products' label do not declare the ingredients of mayonnaise.

________
PRODUCT
Inari Sushi (tofu sushi), net weight 6.50 pounds. Recall #F-257-9.

CODE
All lot numbers beginning with 30.

MANUFACTURER
Fifo Food Systems, Inc., Gardena, California.

RECALLED BY
Manufacturer, by fax on January 20, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
California and Illinois.

QUANTITY
Undetermined.

REASON
Product contains undeclared wheat.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________
PRODUCT
Aspirin Tablets, USP, Chewable, Orange Flavored, 81 mg (1-1/4 grain), in 100 tablets (10 x 10 blister cards), NDC #62584-645-01, and 750 tablets (25 x 30 blister cards), NDC #62584-645-33. Recall #D-135-9.

CODE
Lot numbers: 4363C, 5542B, 6191A, 6192A, 8034B, 8716B, 4363B, 5542A, 6191B, 6192B, 6192C, 8034A, 8276, 8716A, and 9315.

MANUFACTURER
LNK International, Inc, Hauppauge, New York.

RECALLED BY
AmeriSource Health Services Corporation, doing business as American Health Packaging, Columbus, Ohio (repacker/responsible firm), by letter on March 2, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Texas, Idaho, Kentucky, Florida, Arizona, Massachusetts, New Jersey, Wisconsin, Pennsylvania, Virginia, Indiana, Oklahoma, New York, Illinois.

QUANTITY
881 units of 25 blister cards X 30 tablets, and 27,558 units of 10 blister cards X 10 tablets were distributed; firm estimated that 654 units (25 X 30) and 20,874 units (10 X 10) remained in distribution channels at time of recall initiation.

REASON
Stability - Out of specification for percent (%) free salicylic acid.

________
PRODUCT
Oxygen, USP, in high pressure M6 size cylinders. Recall #D-141-9.

CODE
Lot #021999X1.

MANUFACTURER
The Complete Home Care, Massillon, Ohio.

RECALLED BY
Manufacturer, by telephone and by letter on March 2, 1999. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
6 cylinders.

REASON
Current good manufacturing practice deviations; including but not limited to improper identity and strength.

________
PRODUCT
Leep Redikit for Gynecological Loop Electrosurgical Excision Procedure, Part #6060. Recall #D-143-9.

CODE

Lot Numbers:  711054L   711144L   711184L   711194L   712124L
712164L   712174L   712184L   712314L   801224L   801234L
802184L   802254L   803054L   803124L   803234L   804014L
804024E   804204E   804294E   80810E    81008E    81024E
81027E    81110E    81122E    81125E    90120E    90129E
90201E.

MANUFACTURER
Cooper Surgical, Inc., Shelton, Connecticut.

RECALLED BY
Manufacturer, by letter on March 1, 1999. Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide.

QUANTITY
27,622 kits were distributed.

REASON
Lack of assurance of sterility for Novocol brand/manufactured Octocaine 100 (Lidocaine HCL 2% and Epinephrine 1:100,000) 1.8 Ml Cartridges packaged in each kit.

________
PRODUCT
Naturade Children's Cough Syrup, OTC, (Glyceryl Guaiacolate (Guaifenesin)) 150 mg/15 ml, in 4 ounce and 8 ounce bottles. Recall #D-144-9.

CODE
Lot #I44047 EXP 9/99.

MANUFACTURER
Irenda Corporation, Los Angeles, California.

RECALLED BY
Naturade, Inc., Paramount, California, by letter dated March 10, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Arizona, California, Colorado, Connecticut, Iowa, Illinois, Indiana, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, Washington state, Wisconsin.

QUANTITY
7,356 4-ounce bottles and 984 8-ounce bottles were distributed.

REASON
Mislabeling - The directions for children 2 to under 6 years of age indicate dosage of 1 (one) tablespoon every 4 hours instead of the correct 1 (one) teaspoon every 4 hours.

_______
PRODUCT
Mapap Tablets, Regular Strength (Acetaminophen) 325 mg, in 1000 tablet bottles, OTC labeled as an aspirin free pain reliever, distributed by Major Pharmaceuticals. NDC #0904-1982-80. Recall #D-145-9.

CODE
Lot #98M422 EXP 12/01.

MANUFACTURER
PDK Laboratories, Inc., Hauppauge, New York.

RECALLED BY
Manufacturer, by letters faxed on February 18, 1999, and mailed on February 23, 1999. Firm-initiated recall ongoing.

DISTRIBUTION

Indiana and California.

QUANTITY
2,797 bottles were distributed; firm estimated that 1,327 bottles remained on market at time of recall initiation.

REASON
Tablet mix-up - Some acetaminophen 500 mg tablets were mixed in bottles of 325 mg tablets.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT

Synthroid (levothyroxine sodium, USP) Tablets, Rx indicated as a
replacement or supplement therapy in patients of any age or state
with hypothyroidism of any etiology: 
a) Synthroid  Tablets (Levothyroxine Sodium Tablets, USP), 88 mcg 
(0.088 mg), 100 tablets in plastic bottles;
b) Synthroid  Tablets (Levothyroxine Sodium Tablets, USP), 100
mcg (0.1 mg), 100 tablets in plastic bottles; 
c) Synthroid  Tablets (Levothyroxine Sodium Tablets, USP), 150
mcg (0.15 mg), 100 tablets in plastic bottles;
d) Synthroid  Tablets (Levothyroxine Sodium Tablets, USP), 175
mcg (0.175 mg), 100 tablets in plastic bottles.
Recall #D-136/139-9.

CODE
Lot numbers: a) 880128, 880138, 880148A, 880168A, 880178; b) 1000818; c) 1500388; d) 1750088A, 1750098, 1750118, 1750118A, 1750128A, 1750138, 1750148, 1750158.

MANUFACTURER
BASF Pharmaceutical Company, Jayuya, Puerto Rico.

RECALLED BY
Knoll Pharmaceutical Company, Mount Olive, New Jersey, by letter on November 28, 1998. Firm-initiated recall complete.

DISTRIBUTION

Nationwide.

QUANTITY

Lot #         Qty Distributed (100 count bottles)
80128          28,140 
880138         37,272 
1750088A       32,256 
1750098        32,228 
1750118        5,388 
1750118A       10,920 
880148A        25,716
880168A        27,540
1750128A       32,136 
1750138        37,992
1500388        3,288
1000818        1,356 
880178         13,056
1750148        6,012
1750158        5,784.

REASON
Stability - Product may not maintain potency for the labeled expiration date due to packaging defect.

_________
PRODUCT
Epinephrine Inhalation Aerosol, USP, 5.5 mg/ml, 1/2 ounce (15 ml), for the temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma disorders, distributed under the Walgreen, Osco, Eckerd, CVS, Menley and James, Marquee, Longs, Select Brands, Drug Guild, Sav-on, American Fare, Major, Quality Choice and Rite Aid labels. Recall #D-140-9.

CODE

Lot No.   NDC No.         Size     Exp Date   Label
RN7836   11917-003-93     15 ml    04/00      Walgreens
         12810-970-99     15 ml    04/00      Osco Drug
         19458-5066-1     15 ml    04/00      Eckerd
         50428-583-20     15 ml    04/00      CVS
         87900-970-99     15 ml    04/00      Menley & James
RN7839   076-00970-15     15 ml    04/00      Marquee
         12333-9477-1     15 ml    04/00      Longs
         15127-970-15     15 ml    04/00      Select Brands
         19458-9001-1     15 ml    04/00      Eckerd
         26032-970-15     15 ml    04/00      Drug Guild
         37097-970-15     15 ml    04/00      Sav-on
         7200-1755-4      15 ml    04/00      American Fare
RN7841   0904-7770-35     15 ml    05/00      Major
         11161-970-99     15 ml    05/00      Quality Choice
         11822-3479-7     15 ml    05/00      Rite Aid
         11917-003-93     15 ml    05/00      Walgreens
         12810-970-99     15 ml    05/00      Osco Drug
         7200-1755-5      15 ml    05/00      American
Fare.

MANUFACTURER
Alpharma, U.S. Pharmaceutical Division, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter on or about January 20, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

Lot No.       NDC            SHIPPED  
RN7836    11917-003-93       13860     
          12810-970-99       5976      
          19458-5066-1       9900      
          50428-583-20       72        
          87900-970-99       22704     
RN7839    076-00970-15       2844      
          12333-9477-1       3996      
          15127-970-15       4356      
          19458-9001-1       13212     
          26032-970-15       1368      
          37097-970-15       2844      
          7200-1755-4        12384     
RN7841    0904-7770-35       2844      
          11161-970-99       2844      
          11822-3479-7       10368      
          11917-003-93       14796      
          12810-970-99       4284       
          7200-1755-5        9720.

REASON
Failure to meet the USP criteria for unit spray and total doses.

________
PRODUCT
Lithobid - Lithium Carbonate, USP 300 mg Slow-Release Tablets, Rx in 1,000 tablet bottles, indicated in the treatment of manic episodes of manic depressive illness. Recall #D-142-9.

CODE
Lot #88406.

MANUFACTURER
Solvay Pharmaceuticals, Inc., Marietta, Georgia.

RECALLED BY
Manufacturer, by letter on February 22, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,378 bottles were distributed.

REASON
Dissolution failure at 18 month stability testing.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Washed; c) Red Blood Cells, Frozen; d) Platelets; e) Platelets, Pheresis; f) Cryoprecipitated, AHF; g) Fresh Frozen Plasma; h) Liquid Plasma; i) Red Blood Cells for Further Manufacture of Non-Inj. Products; j) Recovered Plasma. Recall #B-545-554-9.

CODE

Unit numbers:  a) 09J08018, 09K04843, 09F29916, 09G84369,
09R31245, 09R31539, 09R31939, 09R32596, 09R33145, 09R33635,
09R35254, 09R35799, 09R36154, 09R47412, 09R48025, 09T76771,
09T80032, 09T89873, 09T93381, 09T99036, 09T07467, 09R25746,
09R26498, 09T81072, 09T96219, 09T12669, 09T27458
b) 09J87941, 09G27971, 09H76084; c) 09J07882, 09G24114
d) 09R35254, 09R35799, 09T80032, 09T81072, 09T96219
e) 09P35110, 09P36786, 09P39521
f) 09Q06362, 09F29916, 09R31245, 09R31539, 09R32596, 09R33635,
09T12669
g) 09P39521, 09R31939, 09R47412, 09R48025, 09T81072, 09T96219,
09T27458 
h) 09G17654, 09J08018, 09T76771, 09T89873, 09T99036, 09R25746,
09T85688, 09T00629
i) 09G91771, 09H62717, 09J12080, 09T85688, 09T76656, 09T09471
j) 09K04843, 09Q06362, 09F29916, 09J87941  09G82515, 09G91771,
09H62717, 09J12080, 09H76084, 09R31245, 09R31539, 09R32596,
09R33145, 09R33635, 09R35254, 09R35799, 09R36154, 09T80032,
09T93381, 09T07467, 09T12072, 09R26498, 09T76656, 09T09471,
09T12669.

MANUFACTURER
American Red Cross Blood Services, Omaha, Nebraska.

RECALLED BY
Manufacturer, by letter dated January 14, 1997, and on January 13, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nebraska, Illinois, California, Iowa, Maryland, North Carolina, Florida, South Dakota.

QUANTITY
a) 27; b) 3 units; c) 2 units; d) 5 units; e) 3 units; f) 7 units; g) 7 units; h) 8 units; i) 6 units; j) 25 units were distributed.

REASON
Blood products tested negative for the antibody to the human immunodeficiency virus (HIV), but were collected from donors who previously tested reactive for the antibody, were distributed.

________
PRODUCT
Platelets, Pheresis. Recall #B-562-9.

CODE
Unit #R00607.

MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.

RECALLED BY
Manufacturer, by telephone on February 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Wisconsin.

QUANTITY
1 unit was distributed.

REASON
Blood product had an unacceptable platelet count.

________
PRODUCT
Source Plasma. Recall #B-565-9.

CODE
Unit #62039611.

MANUFACTURER
Interstate Blood Bank, Inc., of Wisconsin, Milwaukee, Wisconsin.

RECALLED BY
Manufacturer, by letter dated March 15, 1996. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was not quarantined after receiving post donation information regarding a history of hepatitis.

________
PRODUCT
Source Plasma. Recall #B-589-9.

CODE
Unit #74030149.

MANUFACTURER
Interstate Blood Bank Inc. of Wisconsin, Kenosha, Wisconsin.

RECALLED BY
Manufacturer, by fax on January 7, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who had a tattoo within 12 months of donation.

________
PRODUCT
Source Plasma. Recall #B-590-9.

CODE
Unit numbers: 91709271, 88989952, 88985985, 88984988, 88981239, 88980492, 88626086, 88622439, 88621616, 88803609, 88800523, 88448787.

MANUFACTURER
Interstate Blood Bank Inc. of Wisconsin, Kenosha, Wisconsin.

RECALLED BY
Manufacturer, by fax on December 26, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
12 units were distributed.

REASON
Blood products were collected from a donor who had previously been deferred for an undocumented reason.

________
PRODUCT
Platelets, Pheresis. Recall #B-592-9.

CODE
Unit #0011645.

MANUFACTURER
The Community Blood Center, Inc., Appleton, Wisconsin.

RECALLED BY
Manufacturer, by letter dated March 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Wisconsin.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who failed to properly respond to a high risk behavior question.

________
PRODUCT
Source Plasma. Recall #B-593-9.

CODE
Unit numbers: 74030323, 70659146, 70657012, 70655902.

MANUFACTURER
Interstate Blood Bank, Inc. of Wisconsin, Kenosha, Wisconsin.

RECALLED BY
Manufacturer, by fax on January 7, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
4 units were distributed.

REASON
Blood products were collected from a donor who had been incarcerated.

________
PRODUCT
Source Plasma. Recall #B-594-9.

CODE
Unit #X016608.

MANUFACTURER
Community Bio-Resources, Green Bay, Wisconsin.

RECALLED BY
Manufacturer, by letter dated August 22, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who was not asked any of the pre-donation donor screening questions.

________
PRODUCT
Red Blood Cells. Recall #B-599-9.

CODE
Unit numbers: 40FW17730 and 40GS42681.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by letter dated December 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois and Massachusetts.

QUANTITY
2 units were distributed.

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

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-390/391-9.

CODE
Unit #J06520.

MANUFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by letter or fax on June 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia and California.

REASON
Blood products were which tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, Western Blot negative.

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PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-582/583-9.

CODE
Unit #42FX73919.

MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.

RECALLED BY
Manufacturer, by letter dated January 8, 1999. Firm-initiated recall complete.

DISTRIBUTION
Ohio and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had received Heptavax within seven days of donation.

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PRODUCT
Fresh Frozen Plasma. Recall #B-591-9.

CODE
Unit #KM11583.

MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.

RECALLED BY
Manufacturer, by telephone on February 25, 1998, and by letter dated March 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Wisconsin.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of red blood cells that were positive for Propionibacterium acnes.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
Defibrillation Electrode Pads Model: Catalog # (p/n): 902402 Packed 1 box of 10 pair with Catalog #902400 Packed 1 box of 5 pair with Catalog #902401 Packed 1 box of 2 pair with Catalog #902404. Recall #Z-732-9.

CODE
All Lots. Part #/Catalog #: 902402 (electrodes). The following part numbers represent the various packaging configurations which contain the electrodes: 902400, 902401, 902404.

MANUFACTURER
Laerdal Medical Corporation, Wappingers Falls, New York.

RECALLED BY
Manufacturer, by letter dated February 11, 1999. Firm-initiated recall ongoing.

DISTRIBUTION Nationwide, Canada, Norway.

QUANTITY
36,000 pair of electrodes were distributed.

REASON
The conductive gel on individual pads can deteriorate into a liquid. Gel deterioration may occur to the extent the electrode pad becomes unusable because it will not adhere to the patient and will not provide adequate electrical contact.

_________
PRODUCT
Progesterone Reagent Microparticle Enzyme Immunoassay. Recall #Z-734-9.

CODE
List No. 7A64-20, Lot Nos. 40868M300, EXP 2/21/99; 2623M200, EXP 4/10/99; 43658M100, EXP 4/24/99; 44002M100, 2/21/99; 44524M200, EXP 5/23/99; 44870M200, EXP 6/30/99; 45085M100, EXP 8/5/99; 45436M300, EXP 8/19/99; 45878M200, EXP 2/21/99; and 48729M200, EXP 10/14/99.

MANUFACTURER
Abbott Laboratories, Abbott Park, Illinois.

RECALLED BY
Manufacturer, by letter on January 29, 1999. Firm-initaited recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
12,408 packs were distributed.

REASON
Product produces elevated calibrator rates and unacceptable precision.

_______
UPDATE
The following statement is issued to clarify the responsiblity issues involving recall Z-667/669-9 published in the Enforecemnt Report for March 3, 1999: The distribution and sale of Amvisc FB in the U.S. was an independent action by World Optics. Neither Lifecore Medical, Inc. nor Bausch & Lomb Surgical, Inc. had any involvement or prior knowledge of the sales of Amvisc FB in the U.S.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
Disposable, sterile, stainless steel, .35 mm ophthalmic scalpels used for surgery. Recall #Z-733-9.

CODE
Part No. 7355G for .55mm blade, Lot #98107614.

MANUFACTURER
Feather Safety Razor Company, Ltd., Osaka, Japan.

RECALLED BY
Oasis Medical, Glendora, California, by telephone on January 6, 7 and 15, 1999. Firm-initiated recall complete.

DISTRIBUTION
California, Indiana, Massachusetts, New Jersey, Ohio, Oklahoma, South Carolina, Tennessee, West Virginia.

QUANTITY
40 boxes were distributed.

REASON
The scalpel handle is etched as a .35 mm scalpel instead of a .55 mm scalpel. The carton and box are labeled as being a .55 mm scalpel.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II

________
PRODUCT
Liquichlor w/ Cerumene (chloramphenicol prednisolone-tetracaine suspension) labeled for the topical treatment of otitis exterma and pyoderma in dogs and cats). Recall #V-039-9.

CODE
Lot #1162 EXP 10-99.

MANUFACTURER
EVSCO, Buena, New Jersey.

RECALLED BY
Manufacturer, by stopping distribution for their warehouse facilities in New Jersey and California on October 1, 1998, and by fax on October 1-2, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
4,758 dozen were distributed.

REASON
Product is subpotent and failed assay tests for active ingredients.

________
PRODUCT
a) Al Sherman High Mash Non-Medicated; b) Al Sherman Low Mash Non-Medicated. Recall #V-040/041-9.

CODE
Manufacturing Date of 1/18/99.

MANUFACTURER
Poulin Grain, Newport, Vermont.

RECALLED BY
Manufacturer. A new shipment of Low Mash was delivered to the farm on January 25, 1999. Tests were performed on a number of cows and their milk after a few days. Tests were negative. The High Mash was removed from the farm and replaced and a subsequent delivery was replaced as part of customer relations. Firm-initiated recall complete.

DISTRIBUTION
New Hampshire.

QUANTITY
a) 24,170 pounds; b) 12,242 pounds were distributed.

REASON
High Mash and Low Mash are nonmedicated feed which were found to contain chlortetracycline and sulfamethazine due to a manufacturing error.

________
PRODUCT
Milk Fever 23% (for the treatment of milk fever in cattle and as a nutritional supplement for bovine), 500 ml per bottle, under the following brands: Radix Labs Sauk Prairie Veterinary Clinic, Prairie du Sac, WI; Town & Country Veterinary Service, Stratford, WI; AgriLabs Calcium Gluconate 23% Solution Sterile, St Joseph, MO (labeled as a sterile source of calcium and other electrolytes with dextrose for treating milk fever in cattle); Pro Labs C-M-P-K Injection (labeled as a treatment of hypocalcemia, hypomagnesium and other conditions): a) (Radix Milk Fever 23%); b) (Agri Labs Calcium Gluconate 23%); c) (Radix Labs CMPK); d) (Pro Labs C-M-P-K Injection). Recall #V-043/046-9.

CODE
Lot numbers : R7N001 - Milk Fever 23% R7L018 - Agri Labs Calcium Gluconate 23% R7N008 - Radix Labs and Pro Labs CMPK.

MANUFACTURER
Radix Laboratories, Inc.,. Eau Claire, Wisconsin.

RECALLED BY
Manufacturer, by letter dated March 4, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Iowa, Minnesota, Missouri, New York, Pennsylvania, California, Massachusetts, Texas, Wisconsin.

QUANTITY
14,140 500-ml bottles of Milk Fever 23% and Agri Labs Calcium Gluconate; 7,060 500-ml bottles of CMPK were distributed.

REASON
Precipitate found in the injectable product at 18 month check (product has 2 year expiration dating).

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III

________
PRODUCT
Vitamin A D3 B12 Injectable, marketed under the following brands: Radix Labs, Eau Claire, WI; VEDCO, St. Joseph, MO, Veterinary Associates, Melrose, MN. Recall #V-042-9.

CODE
Lot #R6L011.

MANUFACTURER
Radix Laboratories, Inc., Eau Claire, Wisconsin.

RECALLED BY
Manufacturer, by letter dated March 8, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Iowa, Kansas, Minnesota, Missouri, Texas.

QUANTITY
672 100-ml bottles were distributed.

REASON
Precipitate found in the injectable product at 18 month check (product has 2 year expiration dating.

END OF ENFORCEMENT REPORT FOR MARCH 24, 1999.

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