Class II
Terminated
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
This recall has been terminated (originally issued February 9, 2022).
- Company
- Ultra Seal Corporation
- Recall Initiated
- January 24, 2022
- Posted
- February 9, 2022
- Recall Number
- D-0466-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 226,390 packets
- Firm Location
- New Paltz, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP deviations
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: AK9565, Exp. Date 04/2022
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