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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

PRODUCT
Slow Fe Tablets, (160 mg dried ferrous sulfate,
USP, equiv. to 50 mg elemental iron), OTC, blister
packaged units of 90 units, indicated for the
treatment of anemia.

Recall #D-079-8.

CODE

Lot numbers: U09868K EXP 7/99, U10076K EXP 8/99, U10077K EXP 8/99.

MANUFACTURER

Novartis Pharmaceutical, West Sussex, England.

RECALLED BY

Novartis Consumer Health, Inc., Summit, New
Jersey, by telephone on September 4, 1997, and
November 24, 1997, and by letters mailed on
September 5, 1997, and December 12, 1997. Firm-initiated recall ongoing.

DISTRIBUTION

California, Georgia, Pennsylvania, Nebraska.

QUANTITY

39,324 cartons were distributed.

REASON

Labeling lacks tetracycline, nursing, and
pregnancy warnings.

 

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.