You Are Here: Interstitial Cystitis Network : Newsroom : Dec 2001

Key IC Medication Recalled by FDA

Some Batches of Atarax Fail To Meet FDA Standards

On Nov. 14, the FDA Enforcement Report (a weekly FDA publication) announced that some Atarax tablets have been recalled. Manufactured by Pfizer Roerig, these are commonly used by IC patients. Here are the details that were published. (http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00719.html)

MEDICATION: 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.

If you are taking Atarax, please call your physician or pharmacy for further instructions!

Learn more about dissolution studies and other FDA requirements for the manufacturing of medications at: http://www.fda.gov/cder/guidance/3615fnl.htm