|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
October 7, 1998
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.
Lot numbers: a) M531R05 EXP 09/00; b) M530T11 EXP 10/00; c) M532R01 EXP 09/00, P532E01 EXP
MD Pharmaceutical Inc., (Medeva Pharmaceuticals), Santa Ana, California.
Manufacturer, on or about September 4, 1998. Firm-initiated recall ongoing.
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.
Product failed content uniformity testing.