Drug recall D-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.
Reason for recall
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Lots and codes
Lot # NB900413, Exp. 12/2020
Recall details
- Recalling firm
- InvaGen Pharmaceuticals, Inc., Hauppauge, NY
- Quantity
- 2,202 bottles
- Distribution
- Nationwide in the U.S.
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 14, 2020
- Terminated
- August 31, 2020
Related products
- Gabapentin – drug information
- NDC 76282-405 Gabapentin · Gabapentin 600 mg/1 · Exelan Pharmaceuticals Inc.
- NDC 76282-406 Gabapentin · Gabapentin 800 mg/1 · Exelan Pharmaceuticals Inc.