Recall: D-1272-2020

Class III - Minor Violations

Class IIIClassification

2020-05-14Initiated

TerminatedStatus

InvaGen Pharmaceuticals, Inc.Firm

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

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

Distribution

Nationwide in the U.S.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.