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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
November 4, 1998

PRODUCT
Nitrostat Sublingual Tablets, (Nitroglycerin) USP, 0.4 mg (1/150 gr), Rx, in bottles of 25. NDC #0071-0570-13. Recall #D-010-9.

CODE
Lot #01317F EXP 1/99.

MANUFACTURER
Warner Lambert Company, Fajardo, Puerto Rico.

RECALLED BY
Parke Davis, Division of Warner Lambert Company, Morris Plain, New Jersey, by letter on October 13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
24,616 units were distributed.

REASON
Subpotent (18 month stability test station).

 

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.