Inopak Ltd

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
0
Inspections
7
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-1312-2019Class IIInstant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless HandApril 22, 2019
D-1317-2019Class IISani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches perApril 22, 2019
D-1316-2019Class IIMild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 April 22, 2019
D-1313-2019Class IIINODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouApril 22, 2019
D-1315-2019Class IIAntibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial SkApril 22, 2019
D-1310-2019Class IIANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.April 22, 2019
D-1311-2019Class IIAQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packApril 22, 2019
D-1314-2019Class IIINOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML poApril 22, 2019
D-1318-2019Class IIAntibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a)April 22, 2019
D-1319-2019Class IIUnison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with eApril 22, 2019
D-0864-2018Class IIOption Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, RingwoodMay 16, 2018
D-0002-2018Class IIOption Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500August 23, 2017
D-0004-2018Class IIChoice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD,August 23, 2017
D-0003-2018Class IIMild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL UniversAugust 23, 2017