Ultra Seal Corporation

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
D-0483-2022Class IICold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, January 24, 2022
D-0477-2022Class IICetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for:January 24, 2022
D-0497-2022Class IIPain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) January 24, 2022
D-0473-2022Class IIEphedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD PJanuary 24, 2022
D-0484-2022Class IIHeadache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packJanuary 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-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-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-0499-2022Class IIPAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423January 24, 2022
D-0468-2022Class IICHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg)January 24, 2022
D-0479-2022Class IILite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, PhysicianJanuary 24, 2022
D-0498-2022Class IIRegular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, SalicylamideJanuary 24, 2022
D-0482-2022Class IIBackache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50January 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-0489-2022Class IISINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tabJanuary 24, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K101522ULTRA SEAL STERILE LUBRICATING JELLYDecember 23, 2010