PlainRecalls
FDA Drug Moderate Class II Terminated

CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040

Reported: February 9, 2022 Initiated: January 24, 2022 #D-0495-2022

Product Description

CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040

Reason for Recall

cGMP deviations

Details

Recalling Firm
Ultra Seal Corporation
Units Affected
447,050 packets
Distribution
Nationwide within the United States
Location
New Paltz, NY

Frequently Asked Questions

What product was recalled?
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040. Recalled by Ultra Seal Corporation. Units affected: 447,050 packets.
Why was this product recalled?
cGMP deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on February 9, 2022. Severity: Moderate. Recall number: D-0495-2022.