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SafetyAlerts
July 26, 2001

Vintage Pharmaceuticals Inc. Recalls Levothyroxine Sodium

Charlotte, NC (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Vintage Pharmaceuticals, Inc. is recalling certain lot(s) of Levothyroxine Sodium because of stability and potency problems through the expiry dates.

NOTE: There are 4 separate recalls listed below.

This is the first public notice of these Class II recalls issued by FDA.

PRODUCT:
Levothyroxine Sodium 0.025 mg - Lots 013030A, 013030B, 013030C.  Recall Number D-258-1.

Levothyroxine Sodium 0.075 mg - Lots 116059A, 116059B. Recall Number D-259-1.

REASON:
The product may not maintain potency through the expiry date.

MANUFACTURER/RECALLING FIRM:
Vintage Pharmaceuticals, Inc., Charlotte, NC

RECALLED BY:
Vintage by letter on 12/18/00

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
Levothyroxine Sodium 0.025 mg. - 22,186 bottles were manufactured and distributed; Levothyroxine Sodium 0.075 mg. - 2,910 bottles were manufactured and distributed.

PRODUCT:
Levothyroxine Sodium 0.075 mg. Rx Tablets, USP under the QT, VPI and URL labels. The product is packaged in 100 and 1000 tablet bottles.  Recall number D-257-1.

Code: Lots 021129A, 021129B, 022129A, 022129B, 022129C, 022129D, 010030A, 010030B, 010030C, 010030D

REASON:
Stability data does not support expiry date

MANUFACTURER/RECALLING FIRM:
Vintage Pharmaceuticals, Inc., Charlotte, NC

RECALLED BY:
Vintage by letter on 1/29/01

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY
36, 578 bottles

PRODUCT:
(Rx) Levothyroxine Sodium, USP Tablets, 25 mcg (0.025mg), 100 and 1,000 tablets. Recall Number D-254-1.

Lots 083100B, 083100C, 018060A, 018060B, 018060C, 018060D

(Rx) Levothyroxine Sodium, USP Tablets, 50 mcg (0.05mg), 100 and 1,000 tablets. Recall Number D-255-1.

Lots 089089I, 089089J, 011030A, 012030A, 012030B, 012030C, 010040A, 119050A, 120050A, 120050B, 120050C, 120050D, 120050E, 014080A, 015080A, 015080B

(Rx) Levothyroxine Sodium, USP Tablets, 75 mcg (0.075mg), 100 and 1,000 tablets.  Recall Number D-256-1.

Lots 148080A, 104080A, 104080B, 104080C, 107070A, 019060A, 019060B, 019060C, 019060D, 019060E, 019060F, 121050A, 121050B, 121050C, 012040A, 012040B, 012040C, 011040A, 011040B, 051090A, 052090A, 052090B, 052090C, 093090A, 093090B, 093090C, 093090D, 094090A, 094090B, 094090C, 094090D, 085100A, 085100B, 085100C, 116059A, 116059B

REASON:
Stability data does not support expiry date

MANUFACTURER/RECALLING FIRM:
Vintage Pharmaceuticals, charlotte, NC

RECALLED BY:
Recalling firm sent a recall notice on 3/7/01.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
16,996 bottles

PRODUCT:
Levothyroxine Sodium Tablet 25 mcg. in bottles of 100's and 1000's. Recall Number D-252-1.

Lots - 029011A, 029011B, 029011D, 030011A, 031011A, 031011B

Levothyroxine Sodium Tablets 50 mcg. in bottles of 100's and 1000's. Recall Number D-253-1.

CODES: Lots - 009040A, 009040B, 009040C, 025070A, 025070B, 025070C, 025070D, 026070A, 073090A, 073090B, 073090C, 073090D, 014100A, 001110A, 001110B, 002110A, 002110B, 002110C

REASON:
Stability; May not maintain potency through the expiration date.

MANUFACTURER/RECALLING FIRM:
Vintage Pharmaceuticals, Inc., Charlotte, NC

RECALLED BY:
Vintage by letter on 3/21/01.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY
Levothyroxine Sodium 0.025 mg. - 21,861 bottles were manufactured and distributed; Levothyroxine Sodium 0.050 mg - 18,718 bottles were manufactured and distributed.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers July 26, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

 
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Health Professional:

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

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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.