Home / Recalls / Ultra Seal Corporation / D-0508-2022

D-0508-2022 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
1,486,050 packets

Product Description

Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Reason for Recall

cGMP deviations

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: AK9566, Exp. Date 04/2022; AK9612, Exp. Date 05/2022

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  • D-0494-2022 Class II — PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet (January 24, 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)