The Recall Desk

FDA (Drugs) recall action 76020

Mylan LLC. recalled 4 products on 2017-02-01

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2017-02-01
Critical
0
Units
588

Why these products were recalled

Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

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.

1–4 of 4

  • ModerateFDA (Drugs)··2017-02-01

    Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

    Mylan LLC is recalling 588 bottles of Temozolomide Capsules, 250 mg, due to customer complaints of broken capsules and loose powder in the bottles.

    Product
    Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-02-01

    Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

    Mylan LLC is recalling Temozolomide Capsules, 140 mg, due to customer complaints of broken or crushed capsules resulting in loose powder in the bottles.

    Product
    Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-02-01

    Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

    Mylan LLC is recalling specific lots of Temozolomide Capsules, 100 mg, because customer complaints reported broken or crushed capsules resulting in loose powder in the bottles.

    Product
    Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-02-01

    Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

    Mylan LLC is recalling Temozolomide Capsules, 180 mg, due to customer complaints of broken or crushed capsules resulting in loose powder in the bottles.

    Product
    Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
    Category
    Distribution
    0 states