FOOD AND DRUG
ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
August 5, 1998PRODUCT
Triamcinolone Acetonide Cream USP, 0.5%, in 15 gram tubes, Rx topical corticosteroid. NDC
#49158-141-20. Recall #D-210-8.
CODE
Lot numbers: M267 EXP 1/2002, K910 EXP 6/2001.
MANUFACTURER
Thames Pharmacal Company, Ronkonkoma, New York.
RECALLED BY
Manufacturer, by letter faxed on July 2, 1998, followed by telephone. Firm-initiated
recall ongoing.
DISTRIBUTION
New York, California, Colorado, Florida, Indiana, Michigan, Ohio, Texas, Puerto Rico.
QUANTITY
28,116 units of lot M267 and 1,641 units of lot K910 were distributed.
REASON
Mispackaging - Some tubes of 0.1% cream were packaged into cartons labeled as 0.5%. |
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