Drug product
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
D-0864-2018
Product summary
- Firm
- Inopak Ltd
- Event
- Event 80196
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1345 cases
- Official record key
drug-enforcement:D-0864-2018
Official wording
Reason: Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Code information: 7302 01 039, 7302 03 039, 7302 01 040 and 7302 01 043
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial contamination
-
Potency or specification failure
out of specification