Recall: D-1229-2020

Class II - Potentially Harmful

Class IIClassification

2020-03-18Initiated

TerminatedStatus

Aurobindo Pharma USA Inc.Firm

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

Reason

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.