InvaGen Pharmaceuticals, Inc. recalls Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrencevill…
- Recall date
- May 14, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1272-2020
- FDA classification
- Class III
- Brand / firm
- InvaGen Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide in the U.S.
Why it was recalled
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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