Class II · Moderate risk
PeriGiene
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
ROYALAB Germ Away Antibacterial Hand Soap
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Drug: Chloroxylenol
- Recalling firm
- Midlab Incorporated
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0090-2025 · 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 Midlab Incorporated
All 2024 recalls
Class II · Moderate risk
Compliance Dishwashing Liquid & Antibacterial Soap
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
Genuine Joe Antibacterial Lotion Soap
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
Array Liquid Antiseptic Handwash
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
boardwalk ANTIBACTERIAL HANDSOAP REFILL
cGMP Deviations: Out of specification results for micro in hand soap products.
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