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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

PRODUCT
Atrohist Plus Sustained Release (SR) Tablets, (Phenylephrine HCL 25 mg/phenylpropanolamine HCL 50 mg/Chlorpheniramine Maleate 8 mg/Hyoscyamine Sulfate 0.19 mg/Atropine Sulfate 0.04 mg/Scopolamine Hydrobromide 0.01 mg), in bottles of 100 and 500 tablets, and 4 tablet samples, Rx, antihistaminic, nasal decongestant and anti-secretory preparation.

Recall #D-132-8.

CODE
Lot numbers: 045056A 046056C 047056A 001086A 002086A 003086A 004086A 022106A 023106C 003017A 004017A 064047B 005087C 006087A.

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

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

DISTRIBUTION
New York.

QUANTITY
537,692 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.