Drug product
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88
D-0083-2024
Product summary
- Event
- Event 93256
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7392 Bottles
- Official record key
drug-enforcement:D-0083-2024
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: DND0058A, Exp. Date 12/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications