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October 18, 2001

Schering Recalls Etrafon Tablets

Kenilworth, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said that Schering Corp is recalling Etrafon Tablets,USP, brand of perphenazine and amitriptyline hydrochloride, each tablet contains perphenazine, USP 2 mg, and amitriptyline hydrochloride, USP 25mg,100 tablet bottles and 100 tablets packaged unit dose, Rx only.

This is the first public notice of this Class lI recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
D-308-1, Etrafon Tablets,USP, brand of perphenazine and amitriptyline hydrochloride, each tablet contains perphenazine, USP 2 mg, and amitriptyline hydrochloride, USP 25mg,100 tablet bottles and 100 tablets packaged unit dose, Rx only.

Codes:
Lot No: 9-ANC-1, Exp. Date September 2001

REASON:
Dissolution Failure (18 Month Stability)

MANUFACTURER/RECALLING FIRM:
Schering Corp Kenilworth, NJ

RECALLED BY:
Manufacturer, by first class letters mailed 8/22/2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
15,477 bottles of 100 and 2,220 unit dose blisters in boxes of 100.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.