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
October 7, 1998

PRODUCT
Methylphenidate Hydrochloride, Rx, USP, used in the treatment of attention deficit disorder and narcolepsy: a) 5 mg in 1,000 tablet bottles; b) 10 mg, in 1,00 tablet bottles; c) 20 mg, in 100 and 1,000 tablet bottles. Recall #D-243/245-8.

CODE
Lot numbers: a) M531R05 EXP 09/00; b) M530T11 EXP 10/00; c) M532R01 EXP 09/00, P532E01 EXP 05/01.

MANUFACTURER
MD Pharmaceutical Inc., (Medeva Pharmaceuticals), Santa Ana, California.

RECALLED BY
Manufacturer, on or about September 4, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
MD label: Lot M532R01 - 960 bottles; Lot M531R05 1,956 bottles; Apothecon label: Lot P532E01 - 9,648 bottles; Lot M530T11 - 2,940 bottles were distributed.

REASON
Product failed content uniformity testing.

 

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.