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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
September 30, 1998

PRODUCT
Loestrin Fe 1/20 Tablets (Norethindrone Acetate/Ethinyl Estradiol, USP and Ferrous Fumarate), 28 tablet units, Rx oral contraceptive. NDC #0071-0913-47 (package of 28) 0071-0913-98 (sample package). Recall #D-240-8.

CODE
Lot numbers: 00447F EXP 4/99, 02818F EXP 1/00, 00367F EXP 7/99, 02887F EXP 7/99.

MANUFACTURER
Warner Lambert Company, Fajardo, Puerto Rico.

RECALLED BY
Parke-Davis, Division of Warner Lambert Company, Morris Plains, New Jersey, by letter on August 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
95,658 units were distributed.

REASON
In-process blend specification failure; loss on drying.

 

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.