August 13, 1997 97-33
RECALLS AND FIELD CORRECTIONS: DRUGS-CLASS II
===========
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PRODUCT Maximum Strength Ecotrin Caplets, 500 mg, in 60 count
bottles, indicated as an analgesic/anti-inflammatory agent.
Recall #D-239-7.
CODE Lot numbers: 6I02A and 5H14A.
MANUFACTURER Smithkline Beecham Pharmaceutical Company, Cidra,
Puerto Rico.
RECALLED BY Smithkline Beecham Consumer Healthcare,
Parsippany, New Jersey, by letter on March 10, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,493 cases of lot 6I02A and 1,633 cases of lot 5H14A
(36 bottles per case) were distributed; firm estimated that 150 cases remained on market at time of recall initiation.
REASON Product failed dissolution testing (stability).
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PRODUCT Health Safe Anti-Bacterial/Antiseptic Polymer Lotion
*** Safe Effective Skin Protection Against Infection (Triclosan 0.3%), in 2, 4, 8, 16, and 32 fluid ounce bottles.
Recall #D-242-7.
CODE Lot #"4".
MANUFACTURER Stanford Personal Care Manufacturer, Saugus,
California.
RECALLED BY AmeriCare Health Products, Marion, Illinois
(distributor), by telephone on July 1, 1997, followed by letter July 7, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Tennessee, Illinois, Virginia, South Carolina,
Wisconsin, Indiana, Maryland, Pennsylvania.
QUANTITY 312 - 2 oz. bottles, 192 - 4 oz. bottles, 204 - 8 oz.
bottles, 432 - 16 oz. bottles and 81 - 32 oz. bottles were distributed, with the firm estimating that 30% of the product remains on the market.
REASON Product contamination with Pseudomonas Aeruginosa.
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PRODUCT Oxygen, USP in D and E high pressure cylinders for
prescription use. Recall #D-243-7.
CODE All lots.
MANUFACTURER Prescription Oxygen Services, Sault Saint Marie,
Michigan.
RECALLED BY Manufacturer, by visit. Firm-initiated recall
completed on July 10, 1997.
DISTRIBUTION Michigan.
QUANTITY Firm estimates none remains on the market.
REASON Current good manufacturing practice deviations.
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PRODUCT Univasc Tablets, Moexipril Hydrochloride), 7.5 mg, in
bottles of 100, used in the treatment of hypertension.
Recall #D-244-7.
CODE Lot 31411.
MANUFACTURER Schwarz Pharma AG, Monheim, Germany.
RECALLED BY Schwarz Pharma, Inc., Mequon, Wisconsin, by letter
on July 28, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 13,010 bottles were distributed; firm estimated that
less than 10 percent of product (1,301 bottles) remained on market at time of recall initiation.
REASON Tablet mix-up: 15 mg tablet found in 7.5 mg bottle.
RECALLS AND FIELD CORRECTIONS: DRUGS-CLASS III ==========
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PRODUCT Amway FormuCare Hydrocortisone Cream USP, 1%, Net
Wt. 28.35 g (1 oz.), in cartons labeled Amway FormuCare Triple Antibiotic Ointment, BACITRACIN-NEOMYCIN SULFATE-POLYMYXIN B SULFATE OINTMENT. Recall #D-240-7.
CODE Lot K500 EXP 7/00.
MANUFACTURER Thames Pharmacal Company, Ronkonkoma, New York.
RECALLED BY Amway Corporation, Ada, Michigan, by letter on
April 25, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 7,464 cases (4 units per case) were distributed.
REASON Packaging mix-up: Some correctly labeled tubes of
hydrocortisone cream were packaged into exterior cartons labeled as triple antibiotic ointment.
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PRODUCT Tripelennamine Hydrochloride Tablets, USP, 50 mg, in
bottles of 100 and 1,000, under the Schein label, an anti-histamine.
Recall #D-245-7.
CODE Lot No. D6G1807.
MANUFACTURER Danbury Pharmacal, Inc., Danbury, Connecticut.
RECALLED BY Manufacturer, by letter dated May 28, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 448 1000-tablet bottles and 384 100-tablet bottles were
distributed.
REASON Subpotency due to low tablet weight.
Alan W Davidson
a.davidson@fip.nl
Alan W Davidson
General Secretary, FIP
a.davidson@fip.nl
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