Drug product
HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11
D-0593-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 BOTTLE
- Official record key
drug-enforcement:D-0593-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 2007346C
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations