Drug recall
Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood…
FDA recall event 78098 · Class II · Inopak Ltd
Key facts
| Event ID | 78098 |
|---|---|
| Recall numbers | D-0002-2018, D-0003-2018, D-0004-2018 |
| Recalling firm | Inopak Ltd |
| Product type | Drugs |
| Products | Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ, Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456, Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump, GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump. |
| Initiation date | Aug 23, 2017 |
| Report date | Oct 11, 2017 |
| Termination date | Apr 20, 2020 |
| City | Ringwood |
| State | NJ |
| Country | United States |
| FEI number | 1000122232 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: