The Recall Desk

FDA (Drugs) recall action 78098

Inopak Ltd recalled 3 products on 2017-10-11

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2017-10-11
Critical
0
Units
—

Why these products were recalled

GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.

GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • SevereFDA (Drugs)··2017-10-11

    Inopak Recalls Antibacterial Hand Wash Due to Potential Bacterial Contamination

    Inopak Ltd is recalling Option Systems and STYLE Antibacterial Hand Wash due to GMP deviations and potential bacterial contamination from a pump.

    Product
    Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-10-11

    Inopak Recalls Mild Healthcare Antibacterial Hand Soap Due to Contamination Risk

    Inopak Ltd is recalling specific batches of Mild Healthcare Antibacterial Hand Soap due to potential bacterial contamination from a defective pump.

    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
    Category
    Distribution
    0 states