Class II · Moderate risk
PeriGiene
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Techni-Care Chloroxylenold 3%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: initiated due to violations of CGMP 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
Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02
Affected NDCs
46706-0222-01
46706-0222-02
Compare with the code on your package — it is the most precise check available.
Drug: Chloroxylenol
- Recalling firm
- Consolidated Chemical, Inc
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0325-2023 · 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.
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 Consolidated Chemical, Inc
All 2023 recalls
Class II · Moderate risk
Humatrix Microclysmic Gel
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
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