The Recall Desk

FDA (Drugs) recall action 79957

Mylan Pharmaceuticals Inc. recalled 2 products on 2018-05-23

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
2018-05-23
Critical
0
Units
38,412

Why these products were recalled

cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure

cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2018-05-23

    Mylan Recalls Amlodipine and Benazapril Capsules Due to Cleaning Deviations

    Mylan Pharmaceuticals is recalling Amlodipine and Benazapril HCL Capsules because cleaning processes for manufacturing equipment were not followed according to procedure.

    Product
    Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-05-23

    Mylan Recalls Amlodipine and Benazapril Capsules Due to Cleaning Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine and Benazapril HCL Capsules because the cleaning process for manufacturing equipment was not followed according to procedure.

    Product
    Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
    Category
    Distribution
    0 states