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
03/05/1991
FDA Enforcement for the week of March 6, 1991
FDA ENFORCEMENT REPORT
FOR MARCH 6, 1991
March 6, 1991
Recalls and Field Corrections:
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: (a) Daingy Brand Kumquats, in 3 ounce packages.
Recall #F-223-1.
Code: Not coded.
Manufacturer: HOI Kong Trading Company, Hong Kong;
Recalled by: Taroco Food Corporation, Jersey City, New Jersey by visit.
Firm-initiated recall complete.
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Distribution: New York.
Quantity: 10 cases (100 packages/case) were distributed.
Reason: Product contained undeclared sulfites.
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Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Fred Meyer brand Mandarin Oranges in light syrup,
in 11 ounce cans. Recall #F-222-1.
Code: Lot numbers: MOZ5/-F21/0224.
Manufacturer: Mitsui Foods, Inc., Hackensack, New Jersey (importer).
Recalled by: Fred Meyer Inc., Portland, Oregon, by electronic mail
December 5, 1990 and January 3 1991. Firm-initiated recall
ongoing.
Distribution: Oregon, Washington state, Alaska, California, Montanna,
Idaho.
Quantity: 4,032 cases were distributed.
Reason: Product has an off odor and taste, contaminated
with machine oil like substance.
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Product: Queen's Sweet Fruit, in 2 ounce packages.
Recall #F-224-1.
Code: Not coded.
Manufacturer: Royal Flag Ind, Inc., Taiwan.
Recalled by: Taroco Food Corporation, Jersey City, New Jersey by visit.
Firm-initiated recall complete.
Distribution: New York
Quantity: 25 cases (100 packages/case) were distributed.
Reason: Product contained undeclared sulfites.
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Product: Publix brand Frozen, Grade A, Fancy Leaf Spinach,
in 10 ounce boxes. Recall #F-225-1.
Code: All lots.
Manufacturer: Patterson Sales, San Francisco, California.
Recalled by: Budd Mayer Company, Jacksonville, Florida, by telephone
October 14, 1989. Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: 1,718 cases (12 boxes/case) were distributed.
Reason: Product is contaminated with a partial rodent carcass.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Synthroid (Levothyroxine Sodium, USP), Tablets, in
hospital unit dose blister packs, in strengths of
50 mcg, 75 mcg, 100 mcg, 112 mcg, 125 mcg, 150 mcg,
200 mcg and 300 mcg. Only the hospital unit dose
blister packs are involved (100 individually sealed
blisters per pack). Recall #D-201/208-1.
Code: Strength (mcg) Lot No. EXP Date
50 B5665 5/91
50 B5773 8/91
50 B6259 12/91
75 B5667 5/91
75 B5774 8/91
75 B6260 12/91
100 B5668 5/91
100 B5775 8/91
100 B6261 12/91
112 B5411 2/91
112 B5669 5/91
112 B5780 8/91
112 B6262 12/91
125 B5670 5/91
125 B5777 8/91
125 B6263 12/91
150 B5409 2/91
150 B5671 5/91
150 B5776 8/91
150 B6264 12/91
200 B5673 5/91
200 B5778 8/91
200 B6265 12/91
300 B5674 5/91
300 B5779 8/91
300 B6266 12/91
Manufacturer: Boots Pharmaceuticals P.R., Inc., Jayuya, Puerto Rico.
Recalled by: Boots Pharmaceuticals, Inc., Shreveport, Louisiana, by
letter February 11, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: Approximately 70,511/100's were distributed.
Reason: Subpotent or potency not assured through expiration date.
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Product: Clonidine Hydrochloride Tablets USP, 0.1 mg, 0.2 mg,
0.3 mg, in bottles of 100, 500 and 1,000, an Rx drug used
for treatment of hypertension, under American Therapeutics,
Best Generics, Major Pharmaceutical, Parmed Pharmaceutical,
Warner Chilcott, Dixon Shane, and Mason Distributors
labels. Recall #D-210/212-1.
Code: Lot No. EXP Date
(a) 010015 1/92
910316 10/91
906164 6/91
812366 12/90
(b) 912405 12/91
911385 11/91
910322 10/91
903071 3/91
812367 12/90
(c) 010016 1/92
910317 10/91
908254 8/91
906165 6/91
904110 4/91
901035 1/91
Manufacturer: American Therapeutics Inc., Bohemia, New York.
Recalled by: Manufacturer, by letter on or about December 21, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates fewer than 250,000 tablets remain on the
market.
Reason: Lack of assurance of bioequivalence and Abbreviated New
Drug Application discrepancies.
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Product: Platelets, Pheresis. Recall #B-112-1.
Code: Unit #27P04778.
Manufacturer: American Red Cross Blood Services, Johnstown,
Pennsylvania.
Recalled by: Manufacturer, by telephone June 17, 1990. Firm-initiated
recall complete.
Distribution: Pennsylvania.
Quantity: 1 unit.
Reason: Blood product which was labeled with an incorrect
expiration date was distributed.
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Product: (a) Red Blood Cells; (b) Cryoprecipated AHF;
(c) Recovered Plasma. Recall #B-121/123-1.
Code: Unit #40FE77640.
Manufacturer: American Red Cross Blood Services, Peoria, Illinois.
Recalled by: Manufacturer, by letter November 29, 1990 and January 4,
1991. Firm-initiated recall ongoing.
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Distribution: Illinois, Switzerland.
Quantity: 1 unit of each component.
Reason: Blood components, collected from a donor who participated
in high risk behavior, were distributed.
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Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-124/125-1.
Code: Unit numbers (a) 40FT05487, 40FT05286, 40FT05096,
40GV67632, 40GV71911;
(b) 40FT05487, 40FT05286, 40FT05096, 40GV67632, 40GV71911.
Manufacturer: American Red Cross, Peoria, Illinois, California.
Recalled by: Manufacturer by telephone September 7, 1990 and
October 23, 1990 and by letter October 8, 1990.
Firm-initiated recall ongoing.
Distribution: Illinois, Maryland, Pennsylvania, California.
Quantity: (a) 5 units; (b) 5 units.
Reason: Blood components, which tested non-reactive for antibody
to human immunodeficiency virus type 1 (anti-HIV-1) but
collected from donors who previously tested repeatably
reactive for anti-HIV-1, were distributed.
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Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-130/132-1.
Code: Unit numbers: (a) 04FJ84026, 04FJ84943, 04FJ88899,
04FK74169, 04FL67294, 04FR15511, 04FR95646, 04GF06274;
(b) 04GF06274; (c) 04FJ84026, 04FJ84943, 04FJ88899,
04FK74169, 04FL67294, 04FR15511, 04FR95646, 04GF06274.
Manufacturer: American Red Cross, Dedham, Massachusetts.
Recalled by: Manufacturer, by telephone between November 2 and 5,
1990. Firm-initiated recall ongoing.
Distribution: Massachusetts, Maine, California, Switzerland.
Quantity: (a) 8 units; (b) 1 unit; (c) 8 units.
Reason: Blood products which were non-reactive for hepatitis B
surface antigen (HBsAg), but collected from donors who
previously tested repeatably reactive for HBsAg, were
distributed.
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EXTENSION NOTE: Timentin, Recall #D-140-1 which appeared in the
January 23, 1991 Enforcement Report has been
extended to include lot numbers NK4729 EXP 12/91 and
NK4723 EXP 12/91.
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Class III -
Product: Foamcoat, Antacid Tablets, 100 chewable tablets, an
OTC product under the following labels:
Peoples Brand, Foaming Antacid Tablets; Finast Foaming
Antacid; Legend, Foaming Antacid Tablets; Hook's
Foaming Antacid Tablets; Valumed, Heartburn Tablets;
Goldline Genaton Antacid; Schein, Hyrdo Mag Antacid
Tablets; Fays, Quality, Anti-Heartburn Tablets;
Major Quality, Acid-Gone, Chewable Antacid
Tablets; Best, Chewable Antacid Tablets; Rugby
Butterscotch Flavor Algenic Alka Antacid; Perry Health
Care, Foaming Antacid Tablets; Rite Aid, Heart Burn
Relief; Happy Harry's Gavacoat Antacid Tablets;
Eckerd, Antacid Tablets. Recall #D-209-1.
Code: All lots bearing EXP date 6/93 - 11/93.
Manufacturer: Guardian Drug Company, Trenton, New Jersey.
Recalled by: Manufacturer, by letter January 11, 1991 followed by
telephone January 12, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 107,676 bottles of 100 tablets and 100,000 bulk tablets
were distributed; firm estimates 86,752 bottles and
60,000 bulk tablets remain on the market.
Reason: Lack of an approved supplement to an Abbreviated New
Drug Application covering the firm's new manufacturing
location.
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Product: Xactdose Alamag Magnesium Aluminum Hydroxide Suspension
USP, 30 ml, an OTC antacid, in unit dose cups, 10 cups per
tray, 10 trays per case. Recall #D-214-1.
Code: Lot #909603 EXP 9/91.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Xactdose, Inc., South Beloit, Illinois (repacker), by
letter February 8, 1991. Firm-initiated recall ongoing.
Distribution: California, Florida, New York.
Quantity: 23 cases were distributed; firm estimates 12 cases
remain on the market.
Reason: The product fails to meet stability requirements.
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Product: Red Blood Cells. Recall #B-113-1.
Code: Unit #27R42581.
Manufacturer: American Red Cross Blood Services, Johnstown, Pennsylvania.
Recalled by: Manufacturer, by telephone January 26, 1990. Firm-initiated
recall complete.
Distribution: Pennsylvania.
Quantity: 1 unit.
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Reason: Blood product, labeled with an incorrect expiration date
and with an incorrect anticoagulant/preservative solution,
was distributed.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: St. Jude Medical Aortic Expanded Cuff Heart Valve.
Recall #Z-211-1.
Code: Serial numbers 222809 through 222818 and 222315.
Manufacturer: St. Jude Medical, Inc., St. Paul, Minnesota.
Recalled by: Manufacturer, by telephone November 27, 1990. Firm-
initiated recall complete.
Distribution: Pennsylvania, Spain, Ireland, United Kingdom, Australia.
Quantity: 11 units.
Reason: The heart valves are labeled as mitral valves but are
aortic expanded cuff valves.
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Class II -
Product: Model PDT-900 System (Argon Pumped Dye Laser), used
for photodynamic therapy. Recall #Z-279-1.
Code: Serial numbers: 891121 and 901373.
Manufacturer: Laser Ionics, Inc., Orlando, Florida.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan February 11, 1991. Firm-initiated
field correction ongoing.
Distribution: New York.
Quantity: 2 units.
Reason: Noncompliance with performance standards for laser
products in that the user information is inadequate
and device lacks safety interlocks.
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Class III -
NONE
VETERINARY PRODUCTS
Class I -
NONE
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Class II -
Product: Bovadine Sanitizing Teat Dip, 1 % Iodine, in 1 gallon jugs.
Recall #V-055-1.
Code: C912-846 EXP 12/90.
Manufacturer: West Agro, Inc., Des Plaines, Illinois.
Recalled by: West Agro, Inc., Kansas City, Missouri, by letter
October 9, 1990. Firm-initiated recall complete.
Distribution: Minnesota, Maine, Wisconsin, New Jersey, Missouri.
Quantity: 812 jugs were distributed; firm estimates none remains
on the market.
Reason: Product discoloration and analysis revealed low pH and
low potency for iodine.
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Class III -
NONE
Seizure Actions Filed:
Product: Drugs (ASCOMP w/Codeine) (91-574-767/768).
Charge: Product is a new drug marketed without an Approved
New Drug Application.
Firm: Anabolic, Inc., Irvine, California.
Filed: January 22, 1991 - U.S. District Court for the Western
District of Tennessee; Civil #91-2064 HB, FDC #66003.
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Product: Various Drugs (90-574-622).
Charge: Products were manufactured under conditions not in
conformity with current good manufacturing practice.
There is no assurance that they meet the safety
requirements of the Act and have the identity and
strength, and meet the quality and purity characteristics,
which they purport and are represented to possess.
Furthermore, one product, Norcet 7.5 mg is also in
violation of the new drug provisions of the Act.
Firm: Abana Pharmaceuticals, Inc., Birmingham, Alabama.
Filed: September 11, 1990 - U.S. District Court for the Northern
District of Alabama; Civil #CV-90-H-01875-s, FDC #65880.
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