PeriGiene
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations: Out of specification results for micro in hand soap products.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
Drug: Chloroxylenol
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 Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
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