D-0002-2018 Class II Terminated
FDA drug recall D-0002-2018 was initiated by Inopak Ltd on Aug 23, 2017 and is designated Class II. Reason for recall: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump The recall status is terminated (terminated Apr 20, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 11, 2017
- Initiation Date
- Aug 23, 2017
- Termination Date
- Apr 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
Reason for Recall
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Distribution Pattern
nationwide
Code Information
Batch Numbers 6718, 6730, 6744, 6754, 6760, 6773, 6784, 6793, 6804, 6812, 6819, 6838, 6846, 6862, 6877, 6890, 6902, 6910, 6919, 6838, 6846, 6862, 6877, 6890, 6902, 6910, 6919, 6938, 6944, Style Batch Numbers 6725, 6732, 6735, 6742, 6756, 6762, 6766, 6770, 6777, 6792, 6798, 6807, 6813, 6816, 6829, 6839, 6868, 6872, 6875, 6891, 6904, 6906, 6914, 6916, 6923, 6932, 6939, 6820
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0002-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026