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
ZEE Antiseptic Wipes
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA
Drug: Benzalkonium
- Recalling firm
- Dukal Corp.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1675-2012 · 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 Dukal Corp.
All 2012 recalls
Class II · Moderate risk
Dukal Corporation BZK Swab
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
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