Recalls / Class II
Class IID-0003-2018
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
- Affected lot / code info
- Batch Numbers 6749, 6909
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-0003-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.