Reported May 27, 2020 · Terminated
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc.,…
InvaGen Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: InvaGen Pharmaceuticals, Inc. · 7 Oser Ave · Hauppauge, NY · 11788-3811
Is this the product you have?
- Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle
- Manufactured forExelan Pharmaceuticals, Inc., Lawrenceville, GA 30046
- Manufactured byInvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05
- Lot codes and dates
Lot # NB900413Exp. 12/2020
- Amount recalled
- 2,202 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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