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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
January, 1998

PRODUCT
Royal Med brand (a) Enteric Coated Aspirin
Tablets, 325 mg, in 100 tablet bottles; b)
Acetaminophen Tablets, 325 mg, in 100 tablet
bottles, OTC products used for the temporary
relief of minor aches, pains, and headaches,
and to reduce fever.

Recall #D-060/061-8.

CODE

Lot #101G45 EXP 5/99.

MANUFACTURER

Geri-Care Pharmaceutical Corporation,
Brooklyn, New York.

RECALLED BY

Manufacturer, by letter dated December 16,
1997, followed by telephone. Firm-initiated
recall ongoing.

DISTRIBUTION

Minnesota, California, Florida Georgia,
Illinois, Massachusetts, Ohio, Pennsylvania,
Texas, Washington state.

QUANTITY

a) 384 bottles; b) 2,821 bottles were
distributed.

REASON

Mislabeling - Some bottles labeled as enteric
coated aspirin contain acetaminophen.

 

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.