Recalls / Class II
Class IID-0339-2019
Product
Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01
- 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
- Lot #:18A18, Exp. 01/2020
Why it was recalled
Superpotent Drug.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 1996 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-12-06
- FDA classified
- 2018-12-18
- Posted by FDA
- 2018-12-26
- Terminated
- 2020-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0339-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.