Ultra Seal Corporation

FDA Regulatory Profile

Summary

Total Recalls
66
510(k) Clearances
1
Inspections
13
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0482-2022Class IIBackache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50January 24, 2022
D-0468-2022Class IICHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg)January 24, 2022
D-0499-2022Class IIPAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423January 24, 2022
D-0465-2022Class IICold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, GuaifeJanuary 24, 2022
D-0494-2022Class IIPAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEJanuary 24, 2022
D-0490-2022Class IIDILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tabletJanuary 24, 2022
D-0469-2022Class IIExtra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab January 24, 2022
D-0503-2022Class IIPEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, MaJanuary 24, 2022
D-0484-2022Class IIHeadache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packJanuary 24, 2022
D-0495-2022Class IICONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical DistJanuary 24, 2022
D-0511-2022Class IICETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, ManufacturedJanuary 24, 2022
D-0512-2022Class IIAYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by HoneywelJanuary 24, 2022
D-0519-2022Class IISinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, ManufactJanuary 24, 2022
D-0513-2022Class IISINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by HonJanuary 24, 2022
D-0466-2022Class IIAERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packeJanuary 24, 2022
D-0515-2022Class IIELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets,January 24, 2022
D-0505-2022Class IICVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, DisJanuary 24, 2022
D-0508-2022Class IINutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured forJanuary 24, 2022
D-0516-2022Class IIREMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters bJanuary 24, 2022
D-0464-2022Class IINasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid &January 24, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K101522ULTRA SEAL STERILE LUBRICATING JELLYDecember 23, 2010