Recalls / Class II
Class IID-0653-2020
Product
Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
- Affected lot / code info
- Lot #: 19819029A3, Exp. 08/2021
Why it was recalled
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-11-19
- FDA classified
- 2020-01-08
- Posted by FDA
- 2019-12-25
- Terminated
- 2023-04-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0653-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.