The Recall Desk

FDA (Drugs) recall action 84607

Mylan Pharmaceuticals Inc. recalled 2 products on 2020-01-29

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
2020-01-29
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

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

1–2 of 2

  • SevereFDA (Drugs)··2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 300 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 150 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
    Category
    Distribution
    0 states