The Recall Desk

FDA (Drugs) recall action 81741

Asclemed USA Inc. dba Enovachem recalled 2 products on 2018-12-26

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2018-12-26
Critical
0
Units
—

Why these products were recalled

Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex

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

1–2 of 2

  • SevereFDA (Drugs)··2018-12-26

    Dyural-40 Injection Kit Recalled for Incorrect Latex Labeling

    Asclemed USA Inc. is recalling Dyural-40 Injection Kits because the product insert incorrectly states that the stoppers do not contain latex, when they actually do.

    Product
    Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-12-26

    Enovachem Recalls Dyural-80 Injection Kits Due to Incorrect Latex Labeling

    Enovachem is recalling Dyural-80 Injection Kits because the product insert incorrectly stated that the stoppers do not contain latex, when they actually contain natural rubber latex.

    Product
    Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
    Category
    Distribution
    0 states