Class II · Moderate risk
2% Chlorhexidine Gluconate* Cloth
Cross Contamination with Other Products
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
Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566
Drug: Chlorhexidine
- Recalling firm
- Inopak Ltd
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1315-2019 · 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 Chlorhexidine recalls
See all
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Class II · Moderate risk
BD ChloraPrep CLear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep CLear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Scrub Teal
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Other recalls by Inopak Ltd
All 2019 recalls
Class II · Moderate risk
Unison Hand Care Products
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.
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
Mild Health Care Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
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