Home / Recalls / Ultra Seal Corporation / D-0497-2022

D-0497-2022 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
887,000 packets

Product Description

Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68

Reason for Recall

cGMP deviations

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: AK9527, Exp. Date 03/2022

Other recalls by Ultra Seal Corporation

  • D-0499-2022 Class II — PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. (January 24, 2022)
  • D-0466-2022 Class II — AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl (January 24, 2022)
  • D-0490-2022 Class II — DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrin (January 24, 2022)
  • D-0503-2022 Class II — PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 1 (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-0505-2022 Class II — CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 3 (January 24, 2022)
  • D-0515-2022 Class II — ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 m (January 24, 2022)
  • D-0484-2022 Class II — Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg (January 24, 2022)
  • D-0468-2022 Class II — CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Ph (January 24, 2022)