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.
Recall initiated: 20200514
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated