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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
December 23, 1998

PRODUCT
Diltiazem Hydrochloride, USP, Extended-Release Capsules, 60 mg, in 100 capsule bottles, used in the treatment of hypertension. NDC #0093-0021-01. Recall #D-039-9.

CODE
Lot numbers: 8425 EXP 7/99 and 8426 EXP 7/99.

MANFACTURER
Teva Pharmaceuticals, Sellersville, Pennsylvania.

RECALLED BY
Manufacturer, by letter on May 11, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
9,133 bottles of lot 8425 and 9,438 bottles of lot 8426 were distributed.

REASON
Dissolution failure (6 month stability).

 

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.