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-0502-2022, 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-0502-2022Class IIPEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, MaJanuary 24, 2022
D-0473-2022Class IIEphedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD PJanuary 24, 2022
D-0498-2022Class IIRegular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, SalicylamideJanuary 24, 2022
D-0487-2022Class IICOLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 PhenylephrineJanuary 24, 2022
D-0505-2022Class IICVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, DisJanuary 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-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-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-0482-2022Class IIBackache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50January 24, 2022
D-0464-2022Class IINasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid &January 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-0500-2022Class IIMAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 894January 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-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-0483-2022Class IICold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, January 24, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K101522ULTRA SEAL STERILE LUBRICATING JELLYDecember 23, 2010