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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.

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.

Lot #21392 EXP 12/01.

BASF Corporation, Shreveport, Louisiana.

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


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

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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