Recalls / Class II
Class IID-1084-2014
Product
Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
- Affected lot / code info
- Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14
Why it was recalled
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 138,970 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-01-14
- FDA classified
- 2014-02-10
- Posted by FDA
- 2014-02-19
- Terminated
- 2015-10-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1084-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.