Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

SafetyAlerts
November 7, 2000

Qualitest Prednisone Tablets and   Qualitest and Vintage Dexamethasone Tablets Recalled

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.

PRODUCT
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.

Recall #D-011/012-1.

CODE
Lot Numbers:

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.

MANUFACTURER
Vintage Pharmaceuticals, Inc., Huntsville, Alabama.

RECALLED BY
Manufacturer, by telephone followed by letter dated August 17, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
a) Nationwide; b) Nationwide and Puerto Rico.

QUANTITY
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.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

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.

###

 

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.