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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 9, 1999

Mylan Pharmaceuticals, Inc. Recalls Crimson Clover Seeds

Morgantown, WV (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Mylan Pharmaceuticals, Inc. is recalling Trifluoperazine HCl Tablets because the product of subpotency (at 3 month stability).

This is the first public notice issued by the FDA.

PRODUCT
Trifluoperazine HCl Tablets, USP,
a) 1mg, in 100 count bottles;
b) 2mg, in 100 count bottles;
c) and 5mg, in 100 and 500 count bottles;
d) Fluphenazine HCl Tablets, USP, 1 mg, in 100 and 500 count bottles, Rx prescribed for the management of the manifestations of psychotic disorders and non-psychotic anxiety.

CODE

Strength Lot No. NDC No. Size
(Tabs)
Exp Date
a/b/c) 1mg E132L 00378-2401-01 100 10/00
2mg E131L 00378-2402-01 100 10/00
5mg E128L 00378-2405-01 100 10/00
5mg E128L 00378-2405-05 500 10/00
d) 1mg E235E 00378-6004-01 100 08/00
1mg E235E 00378-6004-05 500 08/00

MANUFACTURER
Mylan Pharmaceuticals, Inc., Morgantown, West Virginia.

RECALLED BY
Manufacturer, by letters on or about April 12, 1999, and May 6, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
a-c) Firm estimated that 14,392 bottles of 100 tablets, and 200 bottles of 500 tablets; d) 9,047 bottles of 100 and 960 bottles of 500 tablets remained on market at time of recall initiation.

Recall #D-233/236-9.

 

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.