Drug product
Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
D-0098-2018
Product summary
- Firm
- Mayne Pharma Inc
- Event
- Event 78544
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,364 bottles
- Official record key
drug-enforcement:D-0098-2018
Official wording
Reason: Failed Dissolution Specifications.
Code information: Lot: #:16F649, Exp: May 2018
Distribution pattern: Nationwide within USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications