FDAFDA · Food and drugs·Recall number D-0466-2022
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
Published February 9, 2022 · Recall initiated: January 24, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultra Seal Corporation
- Distributor
- Nationwide within the United States
- Lot
- Lot #: AK9565, Exp. Date 04/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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