December 12, 2000Watson Pharmaceutical Inc.
Recalls Ibuprofen Tablets in Blister Packs
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.
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.
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