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SafetyAlerts
November 15, 2001

Pfizer Recalls Atarax tablets (hydroxyzine HCl)

New York, NY  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Pfizer, Inc is recalling Atarax tablets (hydroxyzine HCl), 10 mg, 100 Tablet bottles.

This is the first public notice of this Class llI recall issued by the FDA.

PRODUCT
Atarax tablets (hydroxyzine HCl), 10 mg, 100 Tablet bottles, Rx only, NDC 0049-5600-66, Pfizer Roerig, Division of Pfizer, Inc., NY, NY,

Recall #D-026-2.

CODE
Lot # 0105K00A, expiration date 7/2002, NDC 0049-5600-66, Item #4341.

RECALLING FIRM/MANUFACTURER

Recalling Firm:
Pfizer, Inc. New York, NY, by letter dated 10/9/01.

Manufacturer:
Pfizer, Inc. Brooklyn, NY. Firm initiated recall is ongoing.

REASON
Dissolution failure (12th month stability).

VOLUME OF PRODUCT IN COMMERCE
24,140 bottles were distributed.

DISTRIBUTION
Nationwide and Puerto Rico, Trinidad, Bahamas and St. Marten
.

 
Selected Recent Recalls


Health Professional:

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

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.