Home / Recalls / Ultra Seal Corporation / D-0465-2022

D-0465-2022 Class II Terminated

Recalled by Ultra Seal Corporation — New Paltz, NY

Recall Details

Product Type: Drugs
Report Date: February 9, 2022
Initiation Date: January 24, 2022
Termination Date: October 16, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 313,000 packets

Product Description

Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040

Reason for Recall

cGMP deviations

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: K9824, Exp. Date 09/2022

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D-0466-2022 Class II — AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl (January 24, 2022)
D-0505-2022 Class II — CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 3 (January 24, 2022)
D-0484-2022 Class II — Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg (January 24, 2022)
D-0495-2022 Class II — CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. (January 24, 2022)
D-0512-2022 Class II — AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packet (January 24, 2022)