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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 24, 1999

PRODUCT
Creomulsion Pediatric Syrup (Dextromethorphan Hydrobromide USP 15mg/15mL, Pseudoephedrine Hydrochloride USP 30mg/15mL, Chlorpheniramine Maleate USP 2mg/15mL), OTC used for the treatment of coughs, colds, and allergies, in 4 fluid ounce bottles. Recall #D-114-9.

CODE
Lot #0Z4 EXP 11/01.

MANUFACTURER
Summit Industries, Marietta, Georgia.

RECALLED BY
Manufacturer, by telephone on December 21, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Tennessee.

QUANTITY

34 cases (12 bottles per case) were distributed.

REASON
Product exceeded microbial specification (Staph warneri).

 

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.