Ultra Seal Corporation

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
D-0468-2022Class IICHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg)January 24, 2022
D-0498-2022Class IIRegular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, SalicylamideJanuary 24, 2022
D-0499-2022Class IIPAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423January 24, 2022
D-0495-2022Class IICONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical DistJanuary 24, 2022
D-0492-2022Class IIPAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packetsJanuary 24, 2022
D-0512-2022Class IIAYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by HoneywelJanuary 24, 2022
D-0513-2022Class IISINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by HonJanuary 24, 2022
D-0484-2022Class IIHeadache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packJanuary 24, 2022
D-0508-2022Class IINutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured forJanuary 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-0511-2022Class IICETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, ManufacturedJanuary 24, 2022
D-0519-2022Class IISinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, ManufactJanuary 24, 2022
D-0482-2022Class IIBackache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50January 24, 2022
D-0516-2022Class IIREMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters bJanuary 24, 2022
D-0476-2022Class IIBack Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PJanuary 24, 2022
D-0518-2022Class IISinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, ManuJanuary 24, 2022
D-0500-2022Class IIMAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 894January 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-0503-2022Class IIPEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, MaJanuary 24, 2022
D-0487-2022Class IICOLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 PhenylephrineJanuary 24, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K101522ULTRA SEAL STERILE LUBRICATING JELLYDecember 23, 2010