Drug & medication recalls Moderate risk

Simvastatin Tablets 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 Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, N…
Recall number
D-1234-2020
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

Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90

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