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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 28, 1999

Goldline Brand Genatap Liquid Antihistamine Nasal Decongestant Recalled

PRODUCT
Goldline brand Genatap Liquid, Antihistamine/Nasal Decongestant (each 15mL contains brompheniramine maleate 2 mg/phenylpropanolamine hydrochloride12.5 mg), in 4 fluid ounce bottles, Rx. NDC #0182-2000-37. Recall #D-172-9.

CODE
Lot #9A05 EXP 1/2001.

MANUFACTURER
Bio-Pharm, Inc., Levittown, Pennsylvania.

RECALLED BY
Zenith Goldline Pharmaceuticals Inc., Miami, Florida, by telephone on March 10-11, 1999, followed by letter dated March 11, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
2,678 bottles were distributed; firm estimated that 2,018 bottles remained on market at time of recall initiation.

REASON
Mislabeling - The immediate bottle label is incorrect, indicating the product to be Genahist Liquid (Diphenhydramine HCl). The holding carton is correctly labeled as Genatap liquid and the product in the bottle is Genatap.

 

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.