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Aurobindo Pharma USA Inc. recalls Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA,

Recalled April 22, 2020 · FDA recall D-1237-2020 · Aurobindo Pharma USA

Hazard
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed · FDA Class II
Units
14707 units
Sold at
Nationwide within the United States

Description

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Product
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
Manufacturer(s)
Aurobindo Pharma USA Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov