FDA recall D-0489-2022

Product

SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00

Reason for recall

cGMP deviations

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-01-24

Report date

2022-02-09

Termination date

2023-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

New Paltz, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2022