Class II · Moderate risk
Unison Hand Care Products
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Mild Health Care Antibacterial Hand Soap
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml Universal Valve pouches per case, 5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-02, INOPAK, LTD., 24 Executive Parkway, Ringwood, NJ 07456.
Affected NDC
5013-0420-02
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Inopak Ltd
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1316-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Inopak Ltd
All 2019 recalls
Class II · Moderate risk
Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Sani-Guard-SF Waterless Foam Hand Sanitizer
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Other cgmp deviation recalls from 2019
All cgmp deviation recalls
Class II · Moderate risk
Yeast Arrest
cGMP violations
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg
Lack of Processing Controls
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