|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
April 22, 1998
Resacol Tablets, OTC analgesic product that is
supposed to contain 325 mg of acetaminophen and 65
mg of caffeine, in bottles of 30.
Lot #960607 EXP 7/98.
Lex Pharmaceutical Corporation, Medly, Florida.
Lyren Pharmaceutical Corporation, Caguas, Puerto
Rico (own label distributor), by letter.
Firm-initiated recall ongoing.
Approximately 2,862 bottles were distributed.
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