D-0653-2020 Class II Terminated
FDA drug recall D-0653-2020 was initiated by AuroMedics Pharma LLC on November 19, 2019 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles.. The recall status is terminated (terminated April 4, 2023).
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2019
- Initiation Date
- November 19, 2019
- Termination Date
- April 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
Reason for Recall
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 19819029A3, Exp. 08/2021