Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

spacer.gif (43 bytes)

FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 28, 1999

Alpharma, U.S. Pharmaceutical Division Haloperidol Oral Solution

PRODUCT
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 NDC#0536-1011-97.
Recall #D-198-9.

CODE
Lot numbers: RP6813 EXP 1/99 and RK7580 EXP 1/99.

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

RECALLED BY
Manufacturer, by letter sent on or about January 20, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
29,580 units were distributed.

REASONMicrobial contamination - Product failed specification for microbial limits test at 12 month stability test station.

 

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.