FDA-Drug2020-05-27Class III
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.
InvaGen Pharmaceuticals, Inc.
Hazard
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Sold states
Nationwide in the U.S.
Affected count
2,202 bottles
Manufactured in
7 Oser Ave, N/A, Hauppauge, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1272-2020Don't want to check this manually?
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