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Recall Observatory FDA recall evidence

Drug 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.

D-1316-2019

April 22, 2019

Class II

Product summary

Firm
Inopak Ltd
Event
Event 82645
Status
Terminated
Classification
Class II
Quantity
17,850 pounds per batch
Official record key
drug-enforcement:D-1316-2019

Official wording

Reason: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Code information: Batch #: 6656, 6959, 7008

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations