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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
May 20, 1998

PRODUCT
Q-Tuss Sustained Release (SR) Tablets (Phenylephrine HCL 25mg/phenylpropanolamine HCL 50 mg/Chlorpheniramine Maleate 8 mg/Hyoscyamine Sulfate 0.19 mg/Atropine Sulfate 0.04 mg/Scopolamine Hydrobromine 0.01 mg), in bottles of 100 and 500, antihistaminic, nasal decongestant and anti-secretory preparation.

Recall #D-131-8.

CODE
043096B 002047B 043096C 015067A 043096D 015067B 043096E 016067A 044096A 016067B 044096B 030106A 001047D 031106A 001047E 031106B 001047F 031106C 002047A 031106D.

MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter dated January 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama.

QUANTITY
78,255 bottles were distributed.

REASON
Incomplete validation data.

 

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.