Home / Recalls / Ultra Seal Corporation / D-0464-2022

D-0464-2022 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
3,508,200 packets

Product Description

Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040

Reason for Recall

cGMP deviations

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: AK9491, AK9496, Exp. Date 02/2022; K9817, Exp. Date 09/2022

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  • D-0469-2022 Class II — Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manuf (January 24, 2022)
  • D-0465-2022 Class II — Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetamin (January 24, 2022)
  • D-0494-2022 Class II — PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet (January 24, 2022)
  • D-0519-2022 Class II — Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tabl (January 24, 2022)
  • 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-0511-2022 Class II — CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count p (January 24, 2022)