Drug product
Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
D-0004-2018
Product summary
- Firm
- Inopak Ltd
- Event
- Event 78098
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0004-2018
Official wording
Reason: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Code information: All lots within expiry
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
GMP Deviations
-
Microbial contamination
bacterial contamination