FDA-Drug2022-02-09Class II

Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02

Ultra Seal Corporation
Hazard

cGMP deviations

Sold states
Nationwide within the United States
Affected count
5,741,384 packets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0484-2022

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