FDA recall D-0490-2022

Ultra Seal Corporation · Class II · drug

Product

DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03

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-0490-2022