FDA-Drug2022-02-09Class II

AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989

Ultra Seal Corporation
Hazard

cGMP deviations

Sold states
Nationwide within the United States
Affected count
226,390 packets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0466-2022

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