Drug product
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
D-0002-2018
Product summary
- Firm
- Inopak Ltd
- Event
- Event 78098
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0002-2018
Official wording
Reason: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
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
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
GMP Deviations
-
Microbial contamination
bacterial contamination