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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
October 7, 1998

PRODUCT
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.

CODE
Lot #C66090 EXP 3/99.

MANUFACTURER
Schwarz Pharma Manufacturing, Inc., Seymour, Indiana.

RECALLED BY
Manufacturer, by letters on July 17, 1998, and on August 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Arkansas, California, Florida, Indiana, Kentucky, Michigan, Mississippi, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas.

QUANTITY
3,010 bottles of 100 tablet bottles, and approximately 187,063 capsules in two count foil packs were distributed.

REASON
Product failed dissolution testing.

 

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.