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October 18, 2001

King Pharmaceuticals Recalls Levoxyl(Levothyroxine Sodium Tablets,USP)

Bristol, TN (SafetyAlerts) - The Food and Drug Administration (FDA) said that King Pharmaceuticals, Inc. is recalling Levoxyl(Levothyroxine Sodium Tablets,USP) 25 mcg (0.025 mg)100 and 1000 tablet bottles, Rx only.

This is the first public notice of this Class lI recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
D-311-1, Levoxyl(Levothyroxine Sodium Tablets,USP) 25 mcg (0.025 mg)100 and 1000 tablet bottles, Rx only

D-312-1, Levoxyl(Levothyroxine Sodium Tablets,USP) 150 mcg (0.15 mg)100 tablet bottles, Rx only

Codes:
25mcg: Lot number 6413, Exp 12/2001
150mcg: Lot number 6294, Exp 11/2001

REASON:
Subpotency (During Stablity)

MANUFACTURER:
King Pharmaceuticals, St. Petersburg, Fl. (formerly Daniels Pharmaceuticals), St. Petersburg, FL

RECALLED BY:
King Pharmaceuticals, Inc. Bristol, TN, by certified mail on 9/19/01.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
19,390 units of lot 6413 and 37,882 units of lot 6294.

 
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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.