Recalls / Class II
Class IID-0864-2018
Product
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
- Affected lot / code info
- 7302 01 039, 7302 03 039, 7302 01 040 and 7302 01 043
Why it was recalled
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
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
- 1345 cases
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-05-16
- FDA classified
- 2018-06-13
- Posted by FDA
- 2018-06-20
- Terminated
- 2020-10-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0864-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.