Recalls / Class II
Class IID-1316-2019
Product
Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml Universal Valve pouches per case, 5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-02, INOPAK, LTD., 24 Executive Parkway, Ringwood, NJ 07456.
- Affected lot / code info
- Batch #: 6656, 6959, 7008
Why it was recalled
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
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
- 17,850 pounds per batch
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-04-22
- FDA classified
- 2019-05-29
- Posted by FDA
- 2019-06-05
- Terminated
- 2024-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1316-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.