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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 22, 1998

PRODUCT
Resacol Tablets, OTC analgesic product that is
supposed to contain 325 mg of acetaminophen and 65
mg of caffeine, in bottles of 30.

Recall #D-116-8.

CODE

Lot #960607 EXP 7/98.

MANUFACTURER

Lex Pharmaceutical Corporation, Medly, Florida.

RECALLED BY

Lyren Pharmaceutical Corporation, Caguas, Puerto
Rico (own label distributor), by letter.
Firm-initiated recall ongoing.

DISTRIBUTION

Puerto Rico.

QUANTITY

Approximately 2,862 bottles were distributed.

REASON

Misbranding - Active ingredient strength
incorrectly labeled: Acetaminophen declared at
.325 mg per tablet sand caffeine at .65 mg
(decimal point incorrectly added in front of each
active ingredient).

 

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.