Drug recall D-427-2013
Product
Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Reason for recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Lots and codes
Lot # a) 64333, Exp. 5/13; 64937, Exp. 6/13; 65629, Exp. 7/13; and 66296, Exp. 9/13; b) 64931, Exp. 5/13 and 65766, Exp. 7/13
Recall details
- Recalling firm
- King Legacy, a wholly owned subsidiary of Pfizer, Bristol, TN
- Quantity
- 103,796 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 30, 2013
- Terminated
- June 30, 2016
Related products
- Levoxyl – drug information
- NDC 60793-860 Levoxyl · Levothyroxine Sodium 200 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 60793-859 Levoxyl · Levothyroxine Sodium 175 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 60793-858 Levoxyl · Levothyroxine Sodium 150 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 60793-853 Levoxyl · Levothyroxine Sodium 88 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 60793-855 Levoxyl · Levothyroxine Sodium 112 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 60793-852 Levoxyl · Levothyroxine Sodium 75 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 60793-850 Levoxyl · Levothyroxine Sodium 25 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 60793-851 Levoxyl · Levothyroxine Sodium 50 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 60793-856 Levoxyl · Levothyroxine Sodium 125 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 60793-854 Levoxyl · Levothyroxine Sodium 100 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 60793-857 Levoxyl · Levothyroxine Sodium 137 ug/1 · Pfizer Laboratories Div Pfizer Inc