Recalls / Class II
Class IID-256-2013
Product
Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) 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) 67343B, Exp. 01/14; b) 66902B, Exp. 12/13
Why it was recalled
Chemical contamination: emission of strong odor after package was opened.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 9213 bottles
- Distribution pattern
- Nationwide and PR
Timeline
- Recall initiated
- 2013-03-28
- FDA classified
- 2013-04-18
- Posted by FDA
- 2013-04-24
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-256-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.