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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 3, 1999

PRODUCT
Triprolidine Hydrochloride and Pseudoephedrine Hydrochloride Syrup USP (1.25mg/5mL and 30mg/5mL) in 4 fluid ounce bottles, OTC oral liquid nasal decongestant/antihistamine, under the Morton Grove Pharmaceuticals (MGP) (NDC #60431-600-04) and Goldline, (NDC #0182-1609-37) labels. Recall #D-124-9.

CODE
Lot numbers: 21377A, 21377C, 21377E, 21377F EXP 07/99.

MANUFACTURER
Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois.

RECALLED BY
Manufacturer, by letter dated February 2, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
14,430 bottles were distributed; firm estimated that little, if any, product remained on market at time of recall initiation.

REASON
Potency failure (triprolidine HCL) during stability testing.

 

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.