Gabapentin Capsules recalled over manufacturing violations
- Recall date
- March 18, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Aurobindo Pharma USA Inc. recalls Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 0881…
- Recall number
- D-1232-2020
- FDA classification
- Class II
- Brand / firm
- Aurobindo Pharma USA Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
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