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SafetyAlerts
September 20, 2000

Cephradine Capsules Recalled by Teva Pharmaceuticals

Fairfield, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Teva Pharmaceuticals USA is recalling its Cephradine Capsules, USP, 500 mg, in 100-count bottles because of subpotency.

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

PRODUCT
Cephradine Capsules, USP, 500 mg, in 100-count bottles, Rx indicated in the treatment of respiratory tract infections, otitis media, skin and skin-structure infections, and urinary tract infections. NDC #0093-3155-01.

Recall #D-460-0.

CODE
Lot Numbers 57450 EXP 9/00 and 57988 EXP 6/01.

MANUFACTURER
Teva Pharmaceuticals USA, Fairfield, New Jersey.

RECALLED BY
Teva Pharmaceuticals USA, Sellersville, Pennsylvania, by letter on August 30, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
10,244 units of lot 057450 and 1,755 units of lot 057988 were distributed; firm estimated that 5 percent of product remained on market at time of recall initiation.

 
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.