The Recall Desk

FDA (Drugs) recall action 75295

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalled 2 products on 2016-11-16

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
2016-11-16
Critical
0
Units
—

Why these products were recalled

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.

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

1–2 of 2

  • LowFDA (Drugs)··2016-11-16

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional, Inc. is recalling specific lots of Clonazepam Tablets, USP, 0.5 mg because they failed impurity specifications.

    Product
    Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2016-11-16

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional is recalling specific lots of Clonazepam 1.0 mg tablets because a known impurity exceeded specification limits during stability testing.

    Product
    Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
    Category
    Distribution
    0 states