November 15, 2001Pfizer Recalls Atarax tablets (hydroxyzine
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
recall issued by the FDA.
Atarax tablets (hydroxyzine HCl), 10 mg, 100 Tablet bottles, Rx only, NDC
0049-5600-66, Pfizer Roerig, Division of Pfizer, Inc., NY, NY,
Lot # 0105K00A, expiration date 7/2002, NDC 0049-5600-66, Item #4341.
Pfizer, Inc. New York, NY, by letter dated 10/9/01.
Pfizer, Inc. Brooklyn, NY. Firm initiated recall is ongoing.
Dissolution failure (12th month stability).
VOLUME OF PRODUCT IN COMMERCE
24,140 bottles were distributed.
Nationwide and Puerto Rico, Trinidad, Bahamas and St. Marten.