Drug & medication recalls Moderate risk

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

Get recall alerts

Free email alert whenever Aurobindo Pharma USA Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Aurobindo Pharma USA Inc.