Inopak Ltd

Complete recall history across all FDA and CPSC categories — 14 total recalls

Inopak Ltd appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (14)

FDA drug safety enforcement actions by Inopak Ltd

Date Product Reason Class
Apr 22, 2019 AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium ch... CGMP Deviations: hand sanitizers and soaps were not produced under current go... Class II
Apr 22, 2019 ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Fo... CGMP Deviations: hand sanitizers and soaps were not produced under current go... Class II
Apr 22, 2019 Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a... CGMP Deviations: hand sanitizers and soaps were not produced under current go... Class II
Apr 22, 2019 Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel... CGMP Deviations: hand sanitizers and soaps were not produced under current go... Class II
Apr 22, 2019 Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE San... CGMP Deviations: hand sanitizers and soaps were not produced under current go... Class II
Apr 22, 2019 INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) ... CGMP Deviations: hand sanitizers and soaps were not produced under current go... Class II
Apr 22, 2019 INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 05857... CGMP Deviations: hand sanitizers and soaps were not produced under current go... Class II
Apr 22, 2019 Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soa... CGMP Deviations: hand sanitizers and soaps were not produced under current go... Class II
Apr 22, 2019 Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with T... CGMP Deviations: hand sanitizers and soaps were not produced under current go... Class II
Apr 22, 2019 Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 m... CGMP Deviations: hand sanitizers and soaps were not produced under current go... Class II
May 16, 2018 Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches... Microbial contamination of NonSterile Product; FDA analysis returned out of s... Class II
Aug 23, 2017 Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Univer... GMP Deviations; potential bacterial contamination may have been introduced to... Class II
Aug 23, 2017 Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Dis... GMP Deviations; potential bacterial contamination may have been introduced to... Class II
Aug 23, 2017 Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18... GMP Deviations; potential bacterial contamination may have been introduced to... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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