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.

Recall Number: D-1272-2020

Firm: InvaGen Pharmaceuticals, Inc.

Classification: Class III

Status: Terminated

Report Date: 20200527

Initiation Date: 20200514

Termination Date: 20200831

Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.

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.