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December 14, 1999

Alpharma USPD, Inc. Recalls Triamcinolone Acetonide Cream

Lincolnton, NC (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Alpharma USPD, Inc. is recalling Triamcinolone Acetonide Cream 0.1% in 1 pound jars, because of lack of assurance that product will meet potency specification over labeled expiration date (superpotency).

This ongoing Class II recall was initiated by the company, by letter on or about September 13, 1999. This is the first notice the FDA has issued to the general public of the recall.

The recalled Triamcinolone Acetonide Cream was sold under the following labels:

NMC Laboratories - NDC 23317-301-16
Lot numbers and expiration dates:
6I561 09/99
6I571 09/99
6I576 09/99
6K715 11/99
6I578 09/99
6K716 11/99
6I581 09/99
6K724 11/99
6I623 09/99
6K750 11/99
6J626 10/99
6L744 12/99
6J627 10/99
6L775 12/99
6J636 10/99
6L793 12/99
6J657 10/99
6L794 12/99
6L820 12/99
6J673 10/99
7A847 01/00

Rugby Laboratories - NDC 0536-5225-98
Lot numbers and expiration dates:
6K705 11/99
6K707 11/99

Major Pharmaceuticals - NDC 0904-2741-27
Lot number and expiration date:
6J657 10/99

Schein Pharmaceuticals - NDC 0364-7212-16
Lot number and expiration date:
6J674 10/99

Although over 102,000 units were distributed nationwide the firm estimated that very little product remained on market at time of recall initiation based on expiration dates.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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