Why it was recalled
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Product description
Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
Lot numbers, UPCs & expiration codes
Lot #: 19819029A3, Exp. 08/2021
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0653-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 19, 2019
- FDA report date
- Dec 25, 2019
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0653-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84308
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: 19819029A3, Exp. 08/2021
- Postal code
- 08520-1401
- Report date
- Dec 25, 2019
- Product type
- Drugs
- Recall number
- D-0653-2020
- Classification
- Class II
- Recalling firm
- AuroMedics Pharma LLC
- Termination date
- Apr 4, 2023
- Reason for recall
- Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 19, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2020