Drug product
Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456
D-0003-2018
Product summary
- Firm
- Inopak Ltd
- Event
- Event 78098
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0003-2018
Official wording
Reason: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Code information: Batch Numbers 6749, 6909
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
GMP Deviations
-
Microbial contamination
bacterial contamination