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.
ENFORCE
03/11/1992
Recalls and Field Corrections: March 11, 1992
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Confectioner's cake and cookie decorations including
colored sugars, nonpareils and decorettes packaged in 6 lb.
cardboard milk cartons, 4 cartons per case.
Recall #F-143/174-2.
1. Brown Sanding Sugar
2. Christmas Mix Decorettes
3. Christmas Mix Nonpareils
4. Carnival Mix Decorettes
5. Rainbow Mix #5 Decorettes
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6. Rainbow Mix #5 Decorette Chips
7. Fiesta Mix Decorettes
8. Green Decorettes
9. Green Nonpareils
10. Green Sanding Sugar
11. Green Con AA Sugar
12. Holly Mix Dec/Nonpareils
13. Jingle Mix Decorettes
14. Jingle Mix Nonpareils
15. Light Green Decorettes
16. Chocolate Green Mint Decorettes
17. Assorted Nonpareils
18. Rainbow Sanding Sugar
19. Rainbow Con AA Sugar
20. Rainbow Mix #7 Decorettes
21. Grover Rainbow Mix Decorettes
22. Rainbow Mix #6 Decorettes
23. Rainbow Party Mix Decorettes
24. Spring Mix Decorettes
25. Spring Mix Nonpareils
26. Sport Mix Decorettes
27. St. Patricks Mix Decorettes
28. Springtime Mix Decorettes
29. Yellow Decorettes
30. Yellow Nonpareils
31. Yellow Sanding Sugar
32. Yellow Con AA Sugar
The products were packaged under the following labels:
QA, Bunge Foods, DecoPac, Mfg. by QA Products, Inc.,
Bensenville, IL
Dawn, Manufactured for Dawn Food Products, Inc., Jackson, MI
Allen, Manufactured for J.W. Allen & Co., Wheeling, IL;
Memphis, TN; Apple Valley MN; Greensboro, NC; Orlando, FL;
Carrollton, TX; Wilmington, MA
Karp's, Manufactured for L. Karp & Sons, Elk Grove Village,
IL Boston Cincinnati Milwaukee Minneapolis
Lawrence Foods, Mfg. for Lawrence Foods, Elk Grove Village,
IL
Ambrosia, Manufactured for Ambrosia Chocolate, Milwaukee, WI
AMPCO, American Products, Dallas, San Antonio, Kingwood
Texas
Azar, Distributed by Azar Nut Company, El Paso, TX
B & K Brand, Byrnes & Kiefer Co., Pittsburgh, PA
Bakery Crafts, Inc., Cincinnati, OH
BB, Best Brands, Inc., St. Paul, Minn.
Cahokia Pride, Manufactured for Cahokia Flour Company, St.
Louis, MO
Catalog Sales, Distributed by Catalog Sales Division,
Greenwood, IN
Speedway/Starvin' Marvin, Distributed by Emro Marketing
Co., Indianapolis, IN
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Lucks, The Lucks Company, Seattle,
Merchants, Merchants Bakery Supplies, Dallas, TX
Mrs. Barrett's Donut Decorations, Distributed by Barrett
Donut Mixes, Inc.
Olender, P. Olender & Co., Detroit, MI, Olender
Corporation, Columbus, OH, Olender/Bessire, Inc., Grand
Rapids, MI
Sparrow, Sparrow Enterprises Ltd., Everett, MA
Spindler, The Spindler Company, North Canton, OH
Steel City, Steel City Milling, Youngstown, Ohio
VBA, Valley Bakers Association, Neenah, Wisconsin
Vanderbilt, Vanderbilt Flour Company, Alsip, IL
Code: All lots
Manufacturer: QA Products, Inc., Bensenville, Illinois.
Recalled by: Manufacturer, by letter February 5, 1992. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 2,000 cases of the various products were distributed in
the last 60 days, with the firm estimating that 5%
of the product remains on the market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Fresh Blackberries packed in 5 ounce baskets, 12 baskets
per flat. Recall #F-180-2.
Code: None. Recall covers a 11/1 and 11/6 shipments.
Manufacturer: Colombian product grown and packed by Delagro S.C.A.
Recalled by: Mrs. Boysen, Inc., Miami, Florida, by telephone
November 7 and 11, 1991, followed by letter. Firm-
initiated recall ongoing.
Distribution: Florida, New York, California.
Quantity: Firm estimates none remains on the market.
Reason: Product contains Permethrin and Cypermethrin which has
no tolerance levels for use in this product.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Roasted lightly salted peanuts packaged in 1/2 ounce
plastic laminate bags for distribution on United Airline
flights, 450 1/2-ounce bags per case. Recall #F-142-2.
Code: 1315 on the 1/2 ounce bags. Cases coded with a pack date
of 11-11-91, item #02986.
Manufacturer: John B. Sanfilippo & Son, Inc., Elk Grove Village, Illinois.
Recalled by: Manufacturer, by letter January 29, 1992, followed by
telephone during the week of February 3, 1992. Firm-
initiated recall ongoing.
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Distribution: Illinois, Hawaii, California, Oregon, Ohio, North Dakota,
Nevada, New Hampshire, Colorado.
Quantity: 400 cases were distributed.
Reason: The peanuts were mislabeled as almonds.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: All unit-dose repacked OTC and Rx drugs packaged by the
recalling firm. This includes a total of 680 different
tablet and capsule products. Recall #D-240-2.
Code: All lots of the drugs repacked between July 1, 1991 and
December 11, 1991. This represents all drugs remaining on
the market and still within the assigned expiry period.
Manufacturer: Various.
Recalled by: Murfreesboro Pharmaceutical Nursing Supply, Inc.,
Murfreesboro, Tennessee (repacker/responsible firm), by
telephone December 12, 1991, followed by letter December
15, 1991. Firm-initiated recall complete.
Distribution: Tennessee.
Quantity: 1,031,780 tablets and capsules were distributed; firm
estimates none remains on the market.
Reason: Mislabeling, product mix-ups, current good manufacturing
practice deficiencies.
----
Product: (a) Anacin Tablets, containing Aspirin 400 mg/Caffeine 32
mg, an OTC analgesic, in 12 count tins and 30, 50, 100,
200 and 300 count bottles;
(b) Maximum Strength Anacin Tablets, containing Aspirin
500 mg/Caffeine 32 mg, coated tablets, an OTC analgesic, in
20, 40, and 75 count bottles. Recall #D-241/242-2.
Code: Lot numbers: (a) K109 - K122, K126, K127, L103-L106,
L109-L111 (tins of 12 tablets); L102-L105 (Bottles of 30);
L106-L109 (bottles of 50); K106, K107, K109, K111, K112,
K113 (bottles of 100); K118, K119, K120 (bottles of 200);
K121 (bottles of 300); (b) K125, K126 (bottles of 20);
K116, K117 (bottles of 40); K114 (bottles of 75). Both
products have a 4 year expiration date.
Manufacturer: Whitehall Laboratories, Inc., Hammanton, New Jersey.
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Recalled by: Whitehall Laboratories, Inc., Division of American Home
Products Corporation, New York, New York, by letter
December 30, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 24,703,536 tablets; (b) 3,265,920 tablets were
distributed; FDA and recalling firm estimates 50% to 75%
of product remain on the market.
Reason: Possible presence of metal particles.
----
Product: Children's Acetaminophen Elixir (OTC), in 4 ounce
bottles, a liquid non-prescription, non-aspirin drug.
Recall #D-243-2.
Code: Lot numbers and EXP dates: YL0081 2/92, YL0111 2/92,
YL0131 2/92, YL0141 2/92, YL0151 2/92, YL0171 2/92,
DL0841 5/93, DL3101 10/93, DL3751 11/93.
Manufacturer: Mova Pharmaceutical Corporation, Villa Blanca, Caguas,
Puerto Rico.
Recalled by: Manufacturer, by letter January 31, 1992. Firm-initiated
recall ongoing.
Distribution: Puerto Rico.
Quantity: 157,118 units were distributed; firm estimates 40,000 units
remain on the market.
Reason: Markings on dosage cup not totally compatible with
label dosage instructions.
----
Product: Various Lannett-manufactured drug products:
(a) Phentermine Tablets, 30 mg; Prednisone Tablets,
5 mg and 20 mg; Amphetamine Sulfate Tablets, 5 mg and 10 mg;
Laniazid Tablets, 50 mg, 100 mg, and 300 mg;
Primidone Tablets, 250 mg; Promethazine HCl Tablets, 12.5 mg,
25 mg, and 50 mg; Diphenylan Sodium Capsules, 30 mg, and
100 mg. Recall #D-245/258-2.
(b) All remaining products that have a valid expiration
date. Recall #D-259-2.
Code: All lots.
Manufacturer: Lannett Company, Inc., Philadelphia, Pennsylvania.
Recalled by: Manufacturer, by letter on or about November 20, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Undetermined.
Reason: (a) Products manufactured without approved supplements
to Abbreviated New Drug Applications;
(b) Current good manufacturing practice deficiencies.
----
Product: Platelets Pheresis. Recall #B-148-2.
Code: Unit #435131.
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Manufacturer: United Blood Services, Blood Systems, Inc., Fargo,
North Dakota.
Recalled by: Consignee telephoned firm September 23, 1991.
Recall complete.
Distribution: North Dakota.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
----
Product: Red Blood Cells, Leukocytes Removed. Recall #B-149-2.
Code: Unit numbers 32M92072, 32FS22542.
Manufacturer: American Red Cross Blood Services, Madison, Wisconsin.
Recalled by: Manufacturer, by letter December 6, 1991.
Firm-initiated recall complete.
Distribution: Wisconsin.
Quantity: 2 units.
Reason: Blood products with incorrect expiration dates were
distributed for transfusion.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF. Recall #B-150/152-2.
Code: Unit #6484313.
Manufacturer: Broward Community Blood Center, Inc., Lauderhill,
Florida.
Recalled by: Manufacturer, by letter November 22, 1991. Firm-initiated
recall ongoing.
Distribution: New York, Florida.
Quantity: 1 unit of each component.
Reason: Blood components drawn from a high risk donor were
distributed.
----
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-153/154-2.
Code: Unit #4607785.
Manufacturer: Department of the Navy, Naval Hospital, Great Lakes,
Illinois.
Recalled by: Manufacturer, by telephone January 27, 1992, followed by
letter January 31, 1992. Firm-initiated recall complete.
Distribution: New York, Illinois.
Quantity: 1 unit of each component.
Reason: Blood products, which tested nonreactive for the antibody
to human immunodeficiency virus type 1 (anti-HIV-1) but
were collected from a donor who previously tested
repeatably reactive for anti-HIV-1, were distributed.
----
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Product: Red Blood Cells, Washed. Recall #B-156-2.
Code: Unit #23F20669.
Manufacturer: American Red Cross Blood Services, Asheville, North
Carolina.
Recalled by: Manufacturer, by letter September 20, 1991. Firm-
initiated recall complete.
Distribution: North Carolina.
Quantity: 1 unit.
Reason: A unit of washed red blood cells labeled with the
incorrect expiration date was distributed.
----
Product: Red Blood Cells, Washed. Recall #B-164-2.
Code: Unit #0206861.
Manufacturer: Community Blood Bank of Erie County. Erie, Pennsylvania.
Recalled by: Manufacturer, by telephone February 18, 1991.
Firm-initiated recall complete.
Distribution: Pennsylvania.
Quantity: 1 unit.
Reason: Blood product, which tested non-reactive for the
antibody to the human T-lymphotropic virus type I
(anti-HTLV-I) but was collected from a donor who
previously tested repeatably reactive for anti-HTLV-I
on two separate occasions, was distributed.
----
Class III -
Product: Buffered Aspirin, 200 mg USP, in 100 tablet bottles.
Recall #D-244-2.
Code: 3/93 D1179C, 7/93 J1143J.
Manufacturer: Hall Laboratories, Inc., Portland, Oregon.
Recalled by: Manufacturer, by letter November 1, 1991. Firm-initiated
recall ongoing.
Distribution: California.
Quantity: 2,076 bottles were distributed.
Reason: Label declares aspirin as 200 mg. Ingredient statement
on label correctly declares aspirin as 325 mg.
----
Product: Various Prescription Drugs. Recall #D-260-2.
Code: All lots.
Manufacturer: Various.
Recalled by: Total Care Pharmacy, Copley, Ohio (repacker/responsible
firm), by letter January 16, 1992. Firm-initiated
recall complete.
Distribution: Ohio.
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Quantity: Undetermined.
Reason: Current good manufacturing practice deficiencies.
----
Product: Dyrenium (Trimaterene) Capsules for oral use, a
potassium-conserving diuretic, 50 mg, in bottles of 100 and
single unit dose 100s in PVC/foil blister packages,
and 100 mg capsules in bottles of 100, 1000 and single unit
dose 100s PVC/foil blister packages. Recall #D-261/262-2.
Code: All lots ending in 7H06, 8H06 (50 mg);
All lots ending in 7H07, 8H07 (100 mg).
Manufacturer: SmithKline Beecham Pharmaceuticals Company, Cidra,
Puerto Rico.
Recalled by: Manufacturer, by letter February 25, 1992. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 76,438 units were distributed; firm estimates none remains
on the market.
Reason: Product does not meet dissolution specifications.
----
Product: Red Blood Cells. Recall #B-155-2.
Code: Unit 03E02710.
Manufacturer: Bloodline, Inc., Elmwood Park, New Jersey.
Recalled by: Manufacturer, by telephone June 20, 1991. Firm-
initiated recall complete.
Distribution: New Jersey.
Quantity: 1 unit.
Reason: Blood product, which tested initially reactive for the
antibody to the human immunodeficiency virus, type 1
(anti-HIV-1), was distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-157/159-2.
Code: Unit #14F39983.
Manufacturer: American Red Cross Blood Services, Yakima, Washington.
Recalled by: Manufacturer, by telephone September 25, 1991, followed
by letter October 14, 1991. Firm-initiated recall complete.
Distribution: Washington state, California.
Quantity: 1 unit of each component.
Reason: Blood products, collected from an ineligible donor due
to rubella immunization less than 4 weeks prior to
donation, were distributed.
----
-8-
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-160/161-2.
Code: Unit #19F26869.
Manufacturer: American Red Cross Blood Services, Nashville, Tennessee.
Recalled by: Manufacturer, by telephone September 27, 1991. Firm-
initiated recall complete.
Distribution: Tennessee, Switzerland.
Quantity: 1 unit of each component.
Reason: Blood products which tested initially reactive for the
hepatitis B surface antigen (HBsAg), were distributed.
----
Product: Red Blood Cells. Recall #B-163-2.
Code: Unit numbers: 12FX08040, 12FX08041, 12FX08042, 12FX08043.
Manufacturer: American Red Cross Blood Services, Charlotte, North Carolina.
Recalled by: Manufacturer, by telephone September 25, 1991, followed by
letter October 7, 1991. Firm-initiated recall complete.
Distribution: North Carolina.
Quantity: 4 units.
Reason: Units of Red Blood Cells labeled with incorrect expiration
dates were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-165/166-2.
Code: Unit numbers: (a) 0214246; (b) 0214256.
Manufacturer: Community Blood Bank of Erie County, Erie, Pennsylvania.
Recalled by: Manufacturer, by telephone March 28-29, 1991.
Firm-initiated recall complete.
Distribution: Pennsylvania.
Quantity: 1 unit of each component.
Reason: Blood products, untested for either the antibody to
the human T-lymphotropic virus type I (anti-HTLV-1), or
hepatitis B surface antigen (HBsAg), were distributed.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Candela Model PLDL-1 Pulsed Dye Laser, used in the
treatment of pigmented lesions. Recall #Z-296-2.
Code: Serial numbers: 81 - 118 (except 84, 102, 106, 107, 112,
113, 114, 115, 117).
Manufacturer: Candela Laser Corporation, Wayland, Massachusetts.
-9-
Recalled by: Manufacturer. FDA approved the firm's corrective action plan
January 23, 1992. Firm-initiated field correction ongoing.
Distribution: Alabama, Arizona, Colorado, California, North Carolina,
Indiana, Nevada, Tennessee, New York, New Jersey,
Mississippi, Texas, South Carolina, Georgia, Nebraska,
Japan, Korea, South Africa, London, Taiwan.
Quantity: 29 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that the purchasers were not provided
a procedure and schedule for calibration of the
measurement system.
----
Correction: Automatic Laser Cutting Machine, Recall #Z-360-2, which
appeared in the March 3, 1992 Enforcement Report should
read:
Code: Serial #00-3279-91. Firm-initiated recall complete.
----
Class III -
Product: (a) Phenytoin Reagent Set; (b) Phenytoin Calibrator Set,
for in-vitro diagnostic use. Recall #Z-365/366-2.
Code: Lot numbers: (a) 01712A; (b) 01720A, 01720B.
Manufacturer: International BioClinical, Inc., Portland, Oregon.
Recalled by: Manufacturer, by letter beginning December 27, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Belgium, France, Poland.
Quantity: 1,067 sets were distributed.
Reason: When these devices are used in tandem, they may not
perform within specifications through the remainder
of the shelf life.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: (a) Monarch Division Protek Teat Dip Germicidal Pre
and Post Milking Teat Dip, in 6 and 15 gallon containers
distributed by H.B. Fuller;
(b) Bou-Matic Super Dip Dermicidial Full Strength Teat
Dip, in 6 gallon containers, manufactured for Bou-Matic
Dairy Equipment Division of DEC International, Inc.
Recall #V-013/014-2.
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Code: Batch code 219110.
Manufacturer: H.B. Fuller Company, Monarch Division, Minneapolis,
Minnesota.
Recalled by: Manufacturer, by telephone December 6, 1991, followed
by letter. Firm-initiated recall ongoing.
Distribution: Midwestern United States.
Quantity: 1,815 gallons in 6 and 15 gallon containers.
Reason: Product is contaminated with bacteria too numerous to count.
----
Product: Furosemide 12.5 and 50 mg Veterinary Tablets, oral solid
dosage form, under the following labels: Biocraft,
Burns Vet Supply, Phoenix Pharmaceutical, Henry Schein.
Recall #V-021-2.
Code: Lot Nos EXP DATE POTENCY
14540 08-01-92 12.5MG
14541 08-01-92 50MG
14869 03-01-92 50MG
14343 04-01-92 50MG
14703 12-01-92 50MG
Manufacturer: Biocraft Laboratories, Inc., Paterson, New Jersey.
Recalled by: Biocraft Laboratories, Inc., Fairlawn, New Jersey, by
letter November 13, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 4,687 50-mg bottles (100s), 6,728 50-mg bottles (500s),
3,851 12.5-mg bottles (500s) were distributed.
Reason: Lack of stability.
----
Class III -
Product: Tribrissen 48% Injection Sterile, in 100 ml bottles, a
Rx for intravenous injection in horses. Recall #V-018-2.
Code: Lot numbers: 80304AL-9, 80304BL-9 EXP 12/93.
Manufacturer: Coopers Animal Health, Inc., Kansas City, Kansas.
Recalled by: Manufacturer, by letter August 16, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 5,484 units were distributed.
Reason: Product failed stability testing.
----
Product: Hilo brand Ear Mite Remedy for dogs and cats, an OTC liquid
veterinary drug. Recall #V-020-2.
Code: Lot numbers 801 and 802.
Manufacturer: Roussel-Bio Uclaf, Lyndhurst, New Jersey.
Recalled by: RocCorp., Inc., North Brunswick, Ohio, by letter
March 21, 1990. Firm-initiated recall complete.
Distribution: Nationwide.
-11-
Quantity: 36,360 of the 1/2 fluid ounce bottles and
approximately 26,028 of the 1 fluid ounce bottles were
distributed.
Reason: Drug is subpotent.
----
Seizure Actions Filed:
Product: L-Arginine, Cystene, L-Ornithine, and L-Phenylalanine
Tablets (91-611-925).
Charge: Products are unapproved new drugs.
Misbranded - Products' labeling lacks adequate directions
for safe and effective for use in the prevention or
treatment of disease conditions for which representations
and suggestions are contrary to fact.
Firm: Vitamin Specialties Company, Wyncote, Pennsylvania.
Filed: August 29, 1991 - U.S. District Court for the Eastern
District of Pennsylvania; Civil #91-4588, FDC #66236.
Seized: July 19, 1991 - goods valued at approximately $13,000.
----
Product: Chunk Light Tuna (91-626-797).
Charge: Adulterated - Product consists in part of decomposed
tuna fish; and the product is pet food which had been
relabeled as human food, thus concealing its inferiority.
Misbranded - Product is offered for sale under the name
of another food.
Firm: Multi-Process International, Inc., New York, New York.
Filed: January 23, 1992 - U.S. District Court for the Eastern
District of New York; Civil #CV-92 0341, FDC #66347.
Seized: January 24, 1992 - approximately 2,842 cases of tuna.
----
Product: Cheddar Cheese Alternative and Monterey Jack Cheese
Alternative (91-632-181).
Charge: Misbranded - Articles are foods which are imitations of
other foods, and their labels fail to bear the word
"imitation" and, immediately thereafter, the names of
the foods imitated.
Firm: Cemac Food Corporation, Philadelphia, Pennsylvania.
Filed: February 12, 1992 - U.S. District Court for the Eastern
District of Pennsylvania; Civil #92-CV-0905; FDC #66341.
Seized: February 20, 1992 - Cheddar Cheese Alternative valued
at $900 and Monterey Jack Cheese Alternative valued
at $368.
----
Product: Butter (91-661-177), Butter Oil (91-661-178)
(91-610-437/8).
-12-
Charge: Adulterated - Butter housed at Berkshire Foods is
filthy because it contains dirt, sand, charred paper
and foreign material as well as a rancid odor; the butter
oil at all three firms was prepared from the fire-damaged
butter and has an odor of smoke.
Firm: Berkshire Foods, Inc., Posen, Illinois; Danish Maid
Butter Company and E.J. Brach Corporation, Chicago, Illinois.
Filed: February 20, 1992 - U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil Nos. 92C1309,
92C1310, #92C1311; FDC Nos. 66334, 66351, and 66352.
Seized: February 24, 1992 - 12,000 pounds of butter and 109 drums
of butter oil valued at over $50,000.
----
Product: Various Repackaged Human Drugs (92-597-541, et al.).
Charge: Adulterated - Methods used in, and the controls used for
their processing and packing do not conform to and are
not operated and administered in conformity with current
good manufacturing practice regulations.
Firm: Pharmacy Dispensing Quantities, Inc., Ft. Scott, Kansas.
Filed: February 26, 1992 - U.S. District Court for the District
of Kansas; Civil #92-2082-0; FDC #66348.
Seized: February 26, 1992 - 220,203 bottles valued at approximately
$8.9 million.
----
Mass Seizures:
Product: Stored Foodstuffs (92-615-281).
Charge: Adulterated - Products consist in whole or in part of a
filthy substance and are held under insanitary conditions
whereby they may have become contaminated by filth.
Firm: United Asian Foods Company, Ltd., Vernon California.
Filed: February 10, 1992 - U.S. District Court for the Central
District of California; Civil #91-0894, FDC #66363.
Seized: February 14, 1992 - foodstuffs valued at approximately
$13,780.
----
Product: Various Foods (92-560-014, et al.).
Charge: Adulterated - Products consist in part of a
filthy substance and have been prepared, packed, and
held under insanitary conditions whereby they may have
become contaminated with filth.
Firm: Rex Pure Foods, Inc., New Orleans, Louisiana.
Filed: February 27, 1992 - U.S. District Court for the
Eastern District of Louisiana; Civil #92-7286, FDC #66386.
----
-13-
Disposition of Injunction:
Defendant: Able Laboratories, Inc., South Plainfield, New Jersey.
Product: Generic Drug Products (91-613-667).
Charge: Adulterated - The methods used for, the manufacture,
processing, packing, or holding do not conform to or
are not operated or administered in conformity with
current good manufacturing practices.
Filed: November 6, 1991 - U.S. District Court for District
of New Jersey; Civil #91-4916(AJL), INJ 1268.
Disposition: March 2, 1992 - An agreed Order signed by both parties
and the District Court Judge was filed.
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