Acetaminophen and Codeine Phosphate 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 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo P…

Recall number

D-1229-2020

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

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