Recalls / Class II
Class IID-0002-2018
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
- Affected lot / code info
- 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
Why it was recalled
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Recalling firm
- Firm
- Inopak Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 24 Executive Pkwy, N/A, Ringwood, New Jersey 07456-1430
Distribution
- Quantity
- N/A
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2017-08-23
- FDA classified
- 2017-10-04
- Posted by FDA
- 2017-10-11
- Terminated
- 2020-04-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0002-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.