Drug product
Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
D-1084-2014
Product summary
- Event
- Event 67399
- Status
- Terminated
- Classification
- Class II
- Quantity
- 138,970 bottles
- Official record key
drug-enforcement:D-1084-2014
Official wording
Reason: Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Code information: Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent