Drug product
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
D-1232-2020
Product summary
- Event
- Event 85183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26625 units
- Official record key
drug-enforcement:D-1232-2020
Official wording
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information: Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations