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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
December 16, 1998

PRODUCT
a) Oxycodone/Acetaminophen, USP 5/500mg Rx Capsules, in bottles of 100, indicated for the relief of moderate to moderately severe pain; b) Tricosal Tablets (Choline Magnesium Trisalicylate), 750 mg, in 100 tablet bottles, Rx, indicated for the relief of the sings and symptoms of rheumatoid arthritis, osteoarthritis, and other arthritides. Recall #D-029\030-9.

CODE
Lot numbers: a) 049097A, EXP 09/99 (NDC #0254-4832-28); 049097B, EXP 09/99 (NDC #0603-4997-21); b) 011047A, EXP 03/99 (NDC #0603-6216-21).

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

RECALLED BY
Manufacturer, by letter dated August 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama.

QUANTITY
a) 4,121 bottles of lot #049097A and 4,843 bottles of lot #049097B; b) 2,909 bottles were distributed.

REASON
a) Lack of assurance of blend uniformity. b) Dissolution failure (12 month stability).

 

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.