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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
July 8, 1998

PRODUCT
Phenylthistine DH Elixir (Pseudoephedrine Hydrochloride 30mg/Codeine Phosphate 10 mg/Chlorpheniramine Maleate 2 mg), in 4 and 16 fluid ounce amber colored plastic bottles, Rx, under theQualitest and Vintage brand labels. NDC #0254-9359-53 & NDC 0603-1520-54 (4 oz.) NDC #0254-9359-58 & NDC #0603-1520-58(16 oz.). Recall #D-164-8.

CODE
Lot numbers: 013J6C, 013J6A, 013J6D, 013J6B.

MANUFACTURER
Vintage Pharmaceuticals, Inc., Huntsville, Alabama.

RECALLED BY
Manufacturer, by letter dated May 7, 1998, followed by telephone. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
4,001 (4 oz.) and 4,224 (16 oz) bottles under the Qualitestlabel; 2,140 (4 oz.) and 1,932 (16-oz.) bottles under the Vintage label were distributed.

REASON
Subpotency - Codeine Phosphate (12 month 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.