|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
April 28, 1999Goldline Brand Genatap Liquid Antihistamine Nasal Decongestant
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.
Lot #9A05 EXP 1/2001.
Bio-Pharm, Inc., Levittown, Pennsylvania.
Zenith Goldline Pharmaceuticals Inc., Miami, Florida, by telephone on March 10-11, 1999,
followed by letter dated March 11, 1999. Firm-initiated recall ongoing.
2,678 bottles were distributed; firm estimated that 2,018 bottles remained on market at
time of recall initiation.
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.