Recalls / Class III
Class IIID-1272-2020
Product
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.
- Brand name
- Gabapentin
- Generic name
- Gabapentin
- Active ingredient
- Gabapentin
- Route
- Oral
- NDCs
- 76282-405, 76282-406
- FDA application
- ANDA202764
- Affected lot / code info
- Lot # NB900413, Exp. 12/2020
Why it was recalled
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Recalling firm
- Firm
- InvaGen Pharmaceuticals, Inc.
- Manufacturer
- Exelan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7 Oser Ave, N/A, Hauppauge, New York 11788-3811
Distribution
- Quantity
- 2,202 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-05-14
- FDA classified
- 2020-05-21
- Posted by FDA
- 2020-05-27
- Terminated
- 2020-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1272-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.