Home / Recalls / Ultra Seal Corporation / D-0473-2022

D-0473-2022 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: 301,842 bottles

Product Description

Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24

Reason for Recall

cGMP deviations

Distribution Pattern

Nationwide within the United States

Code Information

Lot#: 18M063, Exp. Date 01/2022; 19G076, Exp. Date 09/2022

Other recalls by Ultra Seal Corporation

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-0497-2022 Class II — Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phe (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)
D-0512-2022 Class II — AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packet (January 24, 2022)
D-0466-2022 Class II — AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl (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-0499-2022 Class II — PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. (January 24, 2022)