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D-0653-2020 Class II Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0653-2020 was initiated by AuroMedics Pharma LLC on Nov 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 Apr 4, 2023).

Recall Details

Product Type: Drugs
Report Date: Dec 25, 2019
Initiation Date: Nov 19, 2019
Termination Date: Apr 4, 2023
Voluntary/Mandated: Voluntary: Firm initiated

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0653-2020
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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