Home / Recalls / Ultra Seal Corporation / D-0487-2022

D-0487-2022 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
226,400 packets

Product Description

COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556

Reason for Recall

cGMP deviations

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: AK9587, Exp. Date 02/2022

Other recalls by Ultra Seal Corporation

  • D-0513-2022 Class II — SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count p (January 24, 2022)
  • D-0519-2022 Class II — Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tabl (January 24, 2022)
  • D-0465-2022 Class II — Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetamin (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-0495-2022 Class II — CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. (January 24, 2022)
  • D-0511-2022 Class II — CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count p (January 24, 2022)
  • D-0512-2022 Class II — AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packet (January 24, 2022)
  • D-0508-2022 Class II — Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packe (January 24, 2022)