November 7, 2000
Huntsville, AL (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Vintage Pharmaceuticals Inc. is recalling certain Qualitest brand Prednisone Tablets and Qualitest and Vintage brands of Dexamethasone Tablets because there is a lack of data to support labeled expiration date.
This is the first public notice of this Class II issued by FDA.
a) Qualitest brand Prednisone Tablets, 10 mg, in 21 and 48 count, unit dose pack, NDC #0603-5333-31 and 0603-5333-15;
b) Dexamethasone Tablets, USP, 0.75 mg, 12 count, unit dose pack, under the Qualitest and Vintage labels.
a) 071F0A and 071F0B;
b) Qualitest Dexamethasone Tablets, USP, 0.75mg, NDC #0603-3191-11,
Lot numbers: 022D9A, 022D9B, 022D9C, 022D9D, 022D9E, 014E9A, 014E9C, 014E9D,
053F9A, 052L9B, 052L9C
Dexamethasone Tablets, USP, 0.75mg, NDC #0254-2667-06, Lot numbers: 022D9F, 014E9B, 014E9E, 052L9A
Vintage Dexamethasone Tablets, USP, 0.75mg, Rx, NDC #0254-2667-06, Lot numbers: 014E9B, 014E9E, 052L9A, 022D9F.
Vintage Pharmaceuticals, Inc., Huntsville, Alabama.
Manufacturer, by telephone followed by letter dated August 17, 2000. Firm-initiated recall ongoing.
a) Nationwide; b) Nationwide and Puerto Rico.
a) 4,483 packages; b) 179,728 packages were distributed.
Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.