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SafetyAlerts
June 9, 1999

UDL Laboratories, Inc. Recalls Trifluoperazine and Fluphenazine Hydrochloride Tablets

Rockford, IL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that UDL Laboratories, Inc. is recalling Trifluoperazine and Fluphenazine Hydrochloride Tablets because of subpotency (at 3 month stability).

PRODUCT
Rx oral tablets in unit dose blister packages of 100 tablets, 10 strips of 10 tablets, indicated for the management of psychotic disorders:
a) Trifluoperazine Hydrochloride Tablets, USP, 1 mg, in unit dose packages of 100 (10 strips of 10 tablets). NDC #51079-572-20
b) Trifluoperazine Hydrochloride Tablets, USP, 2 mg, in unit dose packages of 100 (10 strips of 10 tablets). NDC #51079-573-20
c) Trifluoperazine Hydrochloride Tablets, USP, 5mg, in unit dose packages of 100 (10 strips of 10 tablets). NDC #51079-574-20
d) Fluphenazine Hydrochloride Tablets, USP, 1 mg, in unit dose packages of 100 (10 strips of 10 tablets).NDC #51079-485-20.

CODE
Lot numbers:
a) 9A159;
b) 9A160 and 9B358;
c) 9A161 and 9C485;
d) 8S844.

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

RECALLED BY
UDL Laboratories, Inc., Rockford, Illinois (repacker), by letter dated May 13, 1999. Firm-initiated recall ongoing. 
This is the first public notice issued by the FDA.

DISTRIBUTION
Nationwide.

QUANTITY
a) 100;
b) 275;
c) 374;
d) 1,404 unit cartons were distributed; firm estimated that 40% of the products remained on the market at time of recall initiation.

Recall #D-238/241-9.

 

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.