Class II · Moderate risk
PeriGiene
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Antiseptic Hand Cleaner (Chloroxylenol)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
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
Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85
Affected NDC
64009-0336-85
Compare with the code on your package — it is the most precise check available.
Drug: Chloroxylenol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Antiseptic Hand Cleaner Chloroxylenol NDC 64009-0336 |
10.11 g/L | Soap Topical |
Spartan Chemical Company, Inc. | OTC |
- Recalling firm
- Spartan Chemical Co Inc
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0361-2021 · 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 Chloroxylenol recalls
See all
Class II · Moderate risk
KleenFoam Antimicrobial Foam Soap
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
DermaKleen
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class I · High risk
PeriGiene
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk
KleenFoam
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Other recalls by Spartan Chemical Co Inc
All 2021 recalls
Class II · Moderate risk
Lite'n Foamy Healthcare Personnel Handwash
CGMP Deviations
Class II · Moderate risk
Lite'n Foamy Eucalyptus Mint Sanitizing Handwash
CGMP Deviations
Class II · Moderate risk
Lite'n Foamy E2 Sanitizing Handwash
CGMP Deviations
Class II · Moderate risk
foamyiQ Lemon Blossom Hand Sanitizer
CGMP Deviations
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