|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
January 13, 1999
Doxepin Hydrochloride Capsules, USP, 10 mg, in unit doses packages of 100, oral
Rx psychotherapeutic agent. NDC #51079-436-20. Recall #D-044-9.
Lot #8C521 EXP 3/00.
Mylan, Inc., Caguas, Puerto Rico.
UDL Laboratories, Rockford, Illinois (repacker), by letter dated December 14, 1998.
Firm-initiated recall ongoing.
1,503 unit cartons were distributed; firm estimated that 25% of product remained on market
at time of recall initiation.
Product failed moisture limits testing (6 month stability).