Recalls / Class II
Class IID-0150-2017
Product
LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01
- 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
- 16H21, Exp. 08/2017
Why it was recalled
Superpotent
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
- 2,666 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-07
- FDA classified
- 2016-11-23
- Posted by FDA
- 2016-11-30
- Terminated
- 2020-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0150-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.