Revitaderm Wound Care
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.
Compare with the code on your package — it is the most precise check available.
Drug: Benzalkonium
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.
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Failed PH Specifications
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
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