|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
February 24, 1999
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.
Lot numbers: RB7111 EXP 8/99, RD7284 EXP 8/99, RD8352 EXP 6/00.
Alpharma, U.S. Pharmaceutical Division, Baltimore, Maryland.
Manufacturer, by letter on or about December 22, 1998. Firm-initiated recall ongoing.
37,212 units were distributed.
Product exhibited cloudiness, precipitation, and/or crystallization. Product also failed
assay for alcohol Content (subpotent).