D-1232-2020 Class II Terminated
FDA drug recall D-1232-2020 was initiated by Aurobindo Pharma USA Inc. on March 18, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed The recall status is terminated (terminated March 25, 2024). Affected quantity: 26625 units.
Recall Details
- Product Type
- Drugs
- Report Date
- April 22, 2020
- Initiation Date
- March 18, 2020
- Termination Date
- March 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26625 units
Product Description
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
Reason for Recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021