Recalls / Class II
Class IID-422-2013
Product
Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
- Brand name
- Levoxyl
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 60793-850, 60793-851, 60793-852, 60793-853, 60793-854, 60793-855, 60793-856, 60793-857, 60793-858, 60793-859 +1 more
- FDA application
- NDA021301
- Affected lot / code info
- Lot # a) 64934, Exp. 4/13; 65059, Exp. 5/13; 65179, Exp. 4/13; 65630, Exp. 7/13; 65916, Exp. 8/13; 66367, Exp. 10/13; and 66718, Exp. 11/13; b) 64338, Exp. 4/13; 64932, Exp. 4/13; 65060, Exp. 5/13; 65235, Exp. 6/13; 65853, Exp. 6/13; and 65962, Exp. 7/13
Why it was recalled
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recalling firm
- Firm
- King Legacy, a wholly owned subsidiary of Pfizer
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 501 5th Street, N/A, Bristol, Tennessee 37620-2304
Distribution
- Quantity
- 195,699 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-04-30
- FDA classified
- 2013-05-20
- Posted by FDA
- 2013-05-29
- Terminated
- 2016-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-422-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.