The Recall Desk

FDA (Drugs) recall action 84550

Asclemed USA Inc. dba Enovachem Pharmaceuticals recalled 3 products on 2020-01-15

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
2020-01-15
Critical
0
Units
—

Why these products were recalled

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

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

States named across these recalls

1–3 of 3

  • ModerateFDA (Drugs)··2020-01-15

    Enovachem Recalls Estriol USP Micronized 0.24 g Due to Impurity Failures

    Enovachem Pharmaceuticals is recalling Estriol USP (Micronized) 0.24 g because additional testing revealed out-of-specification impurity results.

    Product
    Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2020-01-15

    Enovachem Recalls Estriol USP 0.06 g Due to Impurity Failures

    Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling Estriol, USP, (Micronized), 0.06 g, due to out-of-specification impurity test results.

    Product
    Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2020-01-15

    Enovachem Recalls Estriol USP Micronized Due to Impurity Test Failures

    Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling specific lots of Estriol, USP, (Micronized), 0.12 g, because additional testing found Out of Specification impurity test results.

    Product
    Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
    Category
    Distribution
    1 state