Ultra Seal Corporation

FDA Regulatory Profile

Ultra Seal Corporation appears in FDA public data with 66 recalls, 1 510(k) clearance, 13 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0477-2022, Class II) was initiated on January 24, 2022. Its most recent 510(k) clearance was granted on December 23, 2010.

Summary

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

Recent Recalls

NumberClassProductDate
D-0477-2022Class IICetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for:January 24, 2022
D-0470-2022Class IILegatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-counJanuary 24, 2022
D-0493-2022Class IIPAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) January 24, 2022
D-0513-2022Class IISINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by HonJanuary 24, 2022
D-0511-2022Class IICETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, ManufacturedJanuary 24, 2022
D-0506-2022Class IIMidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP PhJanuary 24, 2022
D-0508-2022Class IINutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured forJanuary 24, 2022
D-0505-2022Class IICVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, DisJanuary 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-0490-2022Class IIDILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tabletJanuary 24, 2022
D-0476-2022Class IIBack Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PJanuary 24, 2022
D-0499-2022Class IIPAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423January 24, 2022
D-0518-2022Class IISinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, ManuJanuary 24, 2022
D-0492-2022Class IIPAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packetsJanuary 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-0512-2022Class IIAYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by HoneywelJanuary 24, 2022
D-0502-2022Class IIPEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, MaJanuary 24, 2022
D-0475-2022Class IIMidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer HeJanuary 24, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K101522ULTRA SEAL STERILE LUBRICATING JELLYDecember 23, 2010