D-0864-2018 Class II Terminated
FDA drug recall D-0864-2018 was initiated by Inopak Ltd on May 16, 2018 and is designated Class II. Reason for recall: Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts The recall status is terminated (terminated Oct 23, 2020). Affected quantity: 1345 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 20, 2018
- Initiation Date
- May 16, 2018
- Termination Date
- Oct 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1345 cases
Product Description
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
Reason for Recall
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Distribution Pattern
Nationwide
Code Information
7302 01 039, 7302 03 039, 7302 01 040 and 7302 01 043
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0864-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026