D-1316-2019 Class II Terminated
FDA drug recall D-1316-2019 was initiated by Inopak Ltd on April 22, 2019 and is designated Class II. Reason for recall: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. The recall status is terminated (terminated August 28, 2024). Affected quantity: 17,850 pounds per batch.
Recall Details
- Product Type
- Drugs
- Report Date
- June 5, 2019
- Initiation Date
- April 22, 2019
- Termination Date
- August 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,850 pounds per batch
Product Description
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.
Reason for Recall
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Distribution Pattern
Nationwide in the USA
Code Information
Batch #: 6656, 6959, 7008