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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
August 12, 1998

PRODUCT
Zenith Goldline brand Hydrocodone Bitartrate and Phenylpropanolamine Hydrochloride Pediatric Syrup (Hydrocordone Bitartrate 2.5 mg/Phenylpropanolamine Hydrochloride 12.5 mg), in 1 pint bottles, Rx. NDC #0182-1153-40. Recall #D-216-8.

CODE
Lot numbers: 21754A and 21754F.

MANUFACTURER
Morton Grove Pharmaceuticals, Morton Grove, Indiana (contract manufacturer).

RECALLED BY
Zenith Goldline, Miami, Florida (responsible firm), by letter mailed on June 11, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
336 pints of lot 21754A and 70 pints of lot 21754F were distributed.

REASON
Mislabeling - Pediatric strength bears the NDC code for the adult strength.

 

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.