Aurobindo Pharma USA Inc. recalls Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Ph
Recalled April 22, 2020 · FDA recall D-1229-2020 · Aurobindo Pharma USA
Hazard
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed · FDA Class II
Units
14194 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
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
Manufacturer(s)
Aurobindo Pharma USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →