FDA (Drugs) recall action 89464

Ultra Seal Corporation recalled 56 products on 2022-02-09

The FDA (Drugs) publishes a recall like this one as 56 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 56 pages.

Products: 56
Announced: 2022-02-09
Critical: 0
Units: 65,567,075

Why these products were recalled

cGMP deviations

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 56

ModerateFDA (Drugs)··2022-02-09
Cold Terminator decongestant recalled for cGMP deviations
Ultra Seal Corporation is voluntarily recalling Cold Terminator decongestant/cold relief tablets due to manufacturing compliance deviations. The recall affects 226,400 packets distributed nationwide.
Product
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
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Lite Remfresh Melatonin Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Lite Remfresh Advanced Ion-Powered Melatonin 0.5mg tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects 25,776 blisters in lots 19E058A and 19E058B with an expiration date of May 2022.
Product
Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Extra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations
Ultra Seal Corporation has voluntarily recalled 1,694,200 packets of Extra Strength Un-Aspirin (acetaminophen 500 mg) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.
Product
EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Cold Tablet with Acetaminophen Recalled for cGMP Deviations
Ultra Seal Corporation is voluntarily recalling Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant packets due to cGMP (current Good Manufacturing Practice) deviations. Approximately 313,000 packets of Lot #K9824 (Exp. Date 09/2022) distributed nationwide are affected.
Product
Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling PEPTIME Energy 250mg caffeine tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 100-count bottles distributed in the United States.
Product
PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Exaprin Pain Reliever Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Exaprin pain reliever tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects approximately 1.14 million packets distributed across the United States.
Product
Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Acetaminophen Pain Reliever Recalled for cGMP Deviations
Ultra Seal Corporation is recalling approximately 1.2 million packets of Maximum Strength Non Aspirin Pain Reliever/Fever Reducer due to current good manufacturing practice (cGMP) deviations. The affected product was distributed nationwide.
Product
Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Multi-Symptom Cramp Relief Drug Recalled for Manufacturing Deviations
Ultra Seal Corporation recalled 1,351,660 packets of Multi-Symptom Cramp Relief nationwide due to current good manufacturing practice (cGMP) deviations. The recall was voluntarily initiated and affects two lots with expiration dates in January and July 2022.
Product
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Backache & Muscle Relief Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Backache & Muscle Relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5.1 million packets distributed across the United States.
Product
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Pain & Sinus Reliever tablets recalled for manufacturing deviations
Ultra Seal Corporation is recalling 887,000 packets of Pain & Sinus Reliever (acetaminophen/phenylephrine) tablets nationwide due to cGMP manufacturing deviations. The recalled product is identified by Lot #AK9527 with expiration date 03/2022.
Product
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
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
MidNite Natural Sleep Aid Chewable Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling MidNite Natural sleep aid chewable tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 90,072 bottles distributed across the United States.
Product
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Drug Recall: Cold Relief Tablets Due to cGMP Deviations
Ultra Seal Corporation is voluntarily recalling Cold Relief tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The affected product is distributed nationwide in the United States.
Product
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Drug Recall: PEPTIME Energy Caffeine Tablets cGMP Violations
Ultra Seal Corporation is recalling PEPTIME Energy 300mg caffeine tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 131,112 packets and 8,064 bottles distributed across the United States.
Product
PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
AERO TAB Cold Relief Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling AERO TAB Cold Relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 226,390 packets of the product distributed nationwide.
Product
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Ephedrine Plus tablets recalled for cGMP manufacturing deviations
Ultra Seal Corporation is recalling Ephedrine Plus tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 301,842 bottles distributed across the United States.
Product
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
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Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Drug Recall: Dologen Caplets for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1 mg) caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations during manufacture.
Product
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02
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Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Drug Recall: PAINAID BRF Back Relief Formula cGMP Deviations
Ultra Seal Corporation is recalling PAINAID BRF Back Relief Formula tablets due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 111,300 packets distributed nationwide.
Product
PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Drug Recall: PEPTIME Energy Tablets cGMP Deviations
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 250mg) tablets distributed nationwide due to manufacturing practice deviations. The recall affects 156,096 packets and 9,648 bottles.
Product
PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Multi Symptom Cold Relief tablets recalled for cGMP deviations
Ultra Seal Corporation is voluntarily recalling 673,160 packets of Multi Symptom Cold Relief tablets distributed nationwide due to cGMP (current Good Manufacturing Practice) deviations.
Product
Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
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Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
PAPENOL acetaminophen 500 mg packets recalled for cGMP deviations
Ultra Seal Corporation is recalling PAPENOL acetaminophen 500 mg (2 tablet packets) nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 533,100 packets with lot numbers K9495 (exp. 02/2022) and AK9614 (exp. 05/2022).
Product
PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Drug Recall: Headache & Congestion Sinus Relief cGMP Deviations
Ultra Seal Corporation is recalling Headache & Congestion Sinus Relief tablets nationwide due to current good manufacturing practice (cGMP) deviations. This is a voluntary Class II recall affecting approximately 5.7 million packets.
Product
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
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Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Pain Terminator Extra Strength Pain Relief Drug Recall
Ultra Seal Corporation is recalling PAIN TERMINATOR extra strength pain relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations detected during manufacturing. The recall affects 1,188,280 packets of the product.
Product
PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Sinus Relief Headache/Nasal Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Sinus Relief Headache/Nasal tablets (acetaminophen 325mg, phenylephrine HCl 5mg) nationwide due to current Good Manufacturing Practice (cGMP) deviations discovered during manufacturing.
Product
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
Category
Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Legatrin PM Pain Reliever/Sleep Aid Recalled for cGMP Deviations
Ultra Seal Corporation is recalling 174,852 bottles of Legatrin PM Pain Reliever/Sleep Aid nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated on January 24, 2022.
Product
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50
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Distribution
0 states
ModerateFDA (Drugs)··2022-02-09
Cold/Sinus Medication Recalled for Manufacturing Process Violations
Ultra Seal Corporation is recalling 301,650 packets of a Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant due to cGMP deviations discovered during manufacturing. The product was distributed nationwide.
Product
Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
Category
Distribution
0 states