Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
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