Why it was recalled
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Product description
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
Lot numbers, UPCs & expiration codes
Lot # NB900413, Exp. 12/2020
Where it was sold
Nationwide in the U.S.
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-1272-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 14, 2020
- FDA report date
- May 27, 2020
- Quantity
- 2,202 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1272-2020, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 85646
- Address
- 7 Oser Ave
- Code information
- Lot # NB900413, Exp. 12/2020
- Postal code
- 11788-3811
- Report date
- May 27, 2020
- Product type
- Drugs
- Recall number
- D-1272-2020
- Classification
- Class III
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- Product quantity
- 2,202 bottles
- Termination date
- Aug 31, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- May 14, 2020
- Initial firm notification
- Letter
- Center classification date
- May 21, 2020