Drug product
Naltrexone 4.5 mg capsule
D-0810-2020
Product summary
- Event
- Event 84527
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 bottles
- Official record key
drug-enforcement:D-0810-2020
Official wording
Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Code information: Lot: 60564:42 Use by: 02/10/2020
Distribution pattern: TX
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or missing