|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
October 7, 1998
Clorfed Capsules Extended Release product, each capsule contains 8 mg
chlorpheniramine maleate, 125 mg pseudoephedrine hydrochloride, in 100 capsule bottles and
in 2 count physician sample foil packs, Rx indicated for relief of upper respiratory tract
and bronchial congestion. NDC #45985-542. Recall #D-248-8.
Lot #C66090 EXP 3/99.
Schwarz Pharma Manufacturing, Inc., Seymour, Indiana.
Manufacturer, by letters on July 17, 1998, and on August 5, 1998. Firm-initiated recall
Alabama, Arkansas, California, Florida, Indiana, Kentucky, Michigan, Mississippi,
Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas.
3,010 bottles of 100 tablet bottles, and approximately 187,063 capsules in two count foil
packs were distributed.
Product failed dissolution testing.