|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
August 12, 1998
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.
Lot numbers: 21754A and 21754F.
Morton Grove Pharmaceuticals, Morton Grove, Indiana (contract manufacturer).
Zenith Goldline, Miami, Florida (responsible firm), by letter mailed on June 11, 1998.
Firm-initiated recall ongoing.
336 pints of lot 21754A and 70 pints of lot 21754F were distributed.
Mislabeling - Pediatric strength bears the NDC code for the adult strength.