Class II · Moderate risk
Revitaderm Wound Care
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Maxim Instant Foam Hand Sanitizer
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303
Drug: Benzalkonium
- Recalling firm
- Midlab Incorporated
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1463-2022 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Benzalkonium recalls
See all
Class II · Moderate risk
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Class I · High risk
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class III · Low risk
Lidocaine Wound Gel
Failed PH Specifications
Class II · Moderate risk
Children's Healthcare of Atlanta
CGMP Deviations
Other recalls by Midlab Incorporated
All 2022 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
ROYALAB Germ Away Antibacterial Hand 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.
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