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SafetyAlerts
October 30, 2002

Alpharma Has Recalled Fluocinonide Cream

(This medication is used to treat swelling, inflammation or itching of skin conditions such as eczema, dermatitis, rashes, insect bites, poison ivy, allergies and other irritations.)

The Food and Drug Administration (FDA) released the following information.

PRODUCT
Fluocinonide Cream USP, 0.05%, Rx only, 15g (0.53oz), 30g (1.1oz), and 60g (2.2oz) tubes. Recall # D-029-3.

CODE
Lot#: L106046, L106047, L106048, L108101, L108102, L108103, L110094, L110095, L110096, L202079.

RECALLING FIRM/MANUFACTURER
Alpharma Uspd, Inc., Lincolnton, NC, by letters on September 30, 2002. Firm initiated recall is ongoing.

REASON
Product exceeded specification for degradant level (18 month stability).

VOLUME OF PRODUCT IN COMMERCE
63852 units, various sizes.

DISTRIBUTION
Nationwide.

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October 31, 2002
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