FDA 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.

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2020-05-14

Report date

2020-05-27

Termination date

2020-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1272-2020