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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
January 13, 1999

PRODUCT
Doxepin Hydrochloride Capsules, USP, 10 mg, in unit doses packages of 100, oral Rx psychotherapeutic agent. NDC #51079-436-20. Recall #D-044-9.

CODE
Lot #8C521 EXP 3/00.

MANUFACTURER
Mylan, Inc., Caguas, Puerto Rico.

RECALLED BY
UDL Laboratories, Rockford, Illinois (repacker), by letter dated December 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,503 unit cartons were distributed; firm estimated that 25% of product remained on market at time of recall initiation.

REASON
Product failed moisture limits testing (6 month stability).

 

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.