Class II · Moderate risk
Unison Hand Care Products
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
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
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
- Recalling firm
- Inopak Ltd
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0864-2018 · 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 recalls by Inopak Ltd
All 2018 recalls
Class II · Moderate risk
Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Sani-Guard-SF Waterless Foam Hand Sanitizer
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Mild Health Care Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Other microbial contamination recalls from 2018
All microbial contamination recalls
Class II · Moderate risk
Medline Remedy Essential Barrier Skin Protectant Ointment
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk
Soothe & Cool Protect Moisture Guard Skin Protectant
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk
Germ Bloc Health Hand Sanitizer Foam
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
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