CLASS II Drug recall · Reported 11 Oct 2017 · FDA Enforcement Report
Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X. recalled by Inopak
Inopak is recalling Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X. and Disc Pump Universal Valve, and, distributed nationwide in the US. The recall was initiated on 23 Aug 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0003-2018
- FDA event ID
- 78098
- Recalling firm
- Inopak, Ringwood, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2017
- FDA classified
- 4 Oct 2017
- Reported
- 11 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
Timeline
| 23 Aug 2017 | Recall initiated by company | |
| 4 Oct 2017 | Classified by FDA | +42 days |
| 11 Oct 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
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
Where it was distributed
nationwide
Questions about this recall
Why was it recalled?
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Which lots are affected?
Batch Numbers 6749, 6909
Where was it sold?
nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 78098This product is part of a recall event; the main page for the event is Option Systems Antibacterial Foaming Hand Wash recalled by Inopak.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Option Systems Antibacterial Foaming Hand Wash recalled by Inopak | Inopak | Processing Deviation | Nationwide | |
| CLASS II | Choice Antibacterial Hand Soap, (ethyl alcohol 61%) recalled by Inopak | Inopak | Processing Deviation | Nationwide |
More recalls from Inopak
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Aquacil instant foaming hand sanitizer recalled by Inopak | Inopak | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Antibacterial Foaming Hand Wash With Moisturizers labeled recalled | Inopak | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol recalled | Inopak | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Instant Waterless Hand Sanitizer, Ethyl Alcohol recalled by Inopak | Inopak | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Antibacterial Hand Soap, Healthcare recalled by Inopak | Inopak | Manufacturing (CGMP) Deviations | Nationwide |