Drug product
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
D-1233-2020
Product summary
- Event
- Event 85183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8040 units
- Official record key
drug-enforcement:D-1233-2020
Official wording
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information: Lot #: 24719001A1, Exp. Date 03/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations