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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 24, 1999

PRODUCT
Thiothixene Hydrochloride Oral Solution, USP, 5 mg/mL, in 30 and 120 mL bottles, Rx, used for the management of manifestations of psychotic disorders, under the Alpharma and Barre labels. NDC numbers: Recall #D-106-9.

CODE
Lot numbers: RB7111 EXP 8/99, RD7284 EXP 8/99, RD8352 EXP 6/00.

MANUFACTURER
Alpharma, U.S. Pharmaceutical Division, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter on or about December 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

37,212 units were distributed.

REASON
Product exhibited cloudiness, precipitation, and/or crystallization. Product also failed assay for alcohol Content (subpotent).

 

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.