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Recall Observatory FDA recall evidence

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

August 23, 2017

Class II

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

    reason.manufacturing_process_control · v1.0.0

    GMP Deviations
  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial contamination