November 7, 2000Qualitest Prednisone Tablets and
Qualitest and Vintage Dexamethasone Tablets Recalled
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,
053F9A, 052L9B, 052L9C
Dexamethasone Tablets, USP, 0.75mg, NDC #0254-2667-06, Lot numbers: 022D9F, 014E9B,
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
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.
Safety Alerts compiles
comprehensive safety recall information for the United States. SafeMail is a free email
service to warn consumers of faulty products and contaminated foods. For complete
information regarding current recalls, past recalls and timely product warning
notification visit: www.safetyalerts.com.