FDAFDA · Food and drugs·Recall number D-1272-2020
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.
Published May 27, 2020 · Recall initiated: May 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GABAPENTIN
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Distributor
- Nationwide in the U.S.
- UPC
- 0376282405902
- Lot
- Lot # NB900413, Exp. 12/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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