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SafetyAlerts
December 12, 2000

Watson Pharmaceutical Inc. Recalls Ibuprofen Tablets in Blister Packs

Florham Park, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Watson Pharmaceutical, Inc. is recalling Ibuprofen Tablets in blister packs because of dissolution failure (3-month stability).

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

PRODUCT
Ibuprofen Tablets, USP, 400 mg, in blister packs 10 x 10 tablets, Rx oral non-steroidal anti-inflammatory agent. NDC #0364-0765-90.

Recall #D-055-1.

CODE
Lot #21392 EXP 12/01.

MANUFACTURER
BASF Corporation, Shreveport, Louisiana.

RECALLED BY
Watson Pharmaceutical, Inc., (formerly Schein Pharmaceutical, Inc.), Florham Park, New Jersey, by letter on November 2, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
5,809 cartons were distributed; firm estimated that less than 5 percent of product remained on market at time of recall initiation.

REASON
Dissolution failure (3-month stability).

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

Notice of this product warning was sent via email to SafetyAlerts subscribers December 12, 2000.  For more information regarding the SafetyAlerts free email alert service please click here.

 
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.