|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
April 28, 1999Alpharma, U.S. Pharmaceutical Division Haloperidol Oral Solution
Haloperidol Oral Solution, USP, Rx for Dropper Dosage Only, 2 mg per mL, in 120 mL units,
indicated for the management of manifestations of psychotic disorders, for Tourette's
Disorder in children and adults, and for treatment of severe behavior problems and
hyperactivity in children, under the Rugby and Barre labels. NDC #0472-0766-94 and
Lot numbers: RP6813 EXP 1/99 and RK7580 EXP 1/99.
Alpharma, U.S. Pharmaceutical Division, Baltimore, Maryland.
Manufacturer, by letter sent on or about January 20, 1999. Firm-initiated recall ongoing.
29,580 units were distributed.
REASONMicrobial contamination -
Product failed specification for microbial limits test at 12 month stability test station.