September 10, 1997 97-37
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
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PRODUCT: Baclofen Tablets. Recall #D-257/258-7
CODE: 10 milligram Lot # 24061, 24382, 24383, 26051,
24970, 24971, 26356, 26357, 26358, 24467,
26468, 26469, 26470.
20 milligram Lot # 24059, 24384,24385, 24964,
24972, 24973, 26353, 26354, 26355.
MANUFACTURER:Teva Pharmaceuticals USA, Incorporated,
Sellerville, Pennsylvianna.
RECALLED BY: Manufacturer, by letter, on July 21, 1997.
Firm-initiated recall on-going.
DISTRIBUTION:Nationwide.
QUANTITY: None remain on market.
REASON: Lack of assurance product will maintain
stability through labeled expiration
date.(Impurity)
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PRODUCT: Baclofen tablets. Recall# D-259/260-7.
CODE: Lot numbers for 10 milligram: 7B634,7F804,
6V356, 7F799. Lot number for 20 milligram.
7A512
MANUFACTURER:UDL Labortories,Incorporated, Rockford
Illinois.
RECALLED BY: Manufacturer, by letter on July 24, 1997.
Firm initiated recall on-going.
DISTRIBUTION:Nationwide.
QUANTITY: 17184 unit cartons 10 miligrams, 2499 unit
cartons 20 miligrams.
REASON: Lack of assurance product will maintain
stability through labeled expiration
date.(Impurity)
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PRODUCT: Guaifenesin LA Caplets. Recall# D-241-7
CODE: Lot # 199.
MANUFACTURER:Pharmafab, Incorporated, Forth Worth, Texas.
RECALLED BY: Alphagen Labortories,Incorporated, by
facsimile on June 18, 1997. Firm-initiated
recall .
DISTRIBUTION:Nationwide.
QUANTITY: 864 bottles were distributed.
REASON: Product was mislabled. Some bottles may
contain pancreatic enzyme capsules.
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PRODUCT: Baclofen Tablets, Recall# D-261-7.
CODE: Lot # 3541-021.
MANUFACTURER:Biocraft Labortories, Incorporated, Elmwood
Park, New Jersey.
RECALLED BY: Vangard Labs, Incorporated, Glasgow, Kentucky.
DISTRIBUTION:Ohio, Kentucky, Tennessee, North Carolina, New
Jersey, Minnesota, California.
QUANTITY: 104 cartons were distributed.
REASON: The manufacturer cannot assure that the
product will meet stability specifications
through its labeled expiration date.(Impurity)
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PRODUCT: Milltown 600 tablets. Recall# D-263-7
CODE: Lot # 5F1032A
MANUFACTURER:Wallace Labortories, Cranbury, New Jersey.
RECALLED BY: Carter-Wallace, Cranbury, New Jersey, by
telephone on May 21, 1997. Firm-initiated
recall complete.
DISTRIBUTION:Nationwide.
QUANTITY: 627 bottles were distributed.
REASON: Dissolution failure.(Stability)
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PRODUCT: Bisacodyl Tablets Recall# D-262-7.
CODE: Lot# 15253, 15368.
MANUFACTURER:Butler PharmaPac, Incorporated, Eligin,
Illinois.
RECALLED BY: Upsher-Smith Laboratories, Incorporated,
Minneapolis, Minnesota. Firm-initiated recall
on-going.
DISTRIBUTION:Nationwide.
QUANTITY: 4,089 boxes were distributed.
REASON: Product failed to meet potency and
disintegration requirements.(Stability)
Alan W Davidson
General Secretary, FIP
a.davidson@fip.nl
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