The Recall Desk

FDA (Drugs) recall action 80782

Mylan Pharmaceuticals Inc. recalled 2 products on 2018-09-19

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
2018-09-19
Critical
0
Units
—

Why these products were recalled

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

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

1–2 of 2

  • LowFDA (Drugs)··2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling 656 bottles of Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing found out-of-specification related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing revealed out-of-specification results for related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
    Category
    Distribution
    0 states