Drug product
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
D-1234-2020
Product summary
- Event
- Event 85183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26976 units
- Official record key
drug-enforcement:D-1234-2020
Official wording
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information: Lot #: 05319004A1, Exp. Date 03/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations