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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
August 26, 1998

PRODUCT
Nitrostat Sublingual Tablets (Nitroglycerin), 0.4 mg (1/150 gr)in bottles of 25, indicated for the acute relief of an attack orprophylaxis of angina pectoris due to coronary artery disease.Recall #D-225-8.

CODE
Lot numbers: 11906F EXP 10/98, 01417F EXP 12/98.

MANUFACTURER
Warner Lambert Company, Fajardo, Puerto Rico.

RECALLED BY
Parke-Davis, Division of Warner Lambert Company, Morris Plain,New Jersey, by letter on June 30, 1998. Firm-initiated recallongoing.

DISTRIBUTION
Nationwide.

QUANTITY
25,657 bottles of lot 11906F and 24,353 bottles of lot 01417Fwere distributed.

REASON
Subpotent at 15 and 18 month stability test stations.

 

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.