FDA recall D-1231-2020

Product

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-03-18

Report date

2020-04-22

Termination date

2024-03-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1231-2020