The Recall Desk

FDA (Drugs) recall action 79977

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalled 2 products on 2018-05-30

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
2018-05-30
Critical
0
Units
—

Why these products were recalled

GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination

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

1–2 of 2

  • SevereFDA (Drugs)··2018-05-30

    Mylan Recalls Loxapine Capsules Due to Cross-Contamination Risk

    Mylan Institutional, Inc. is recalling Loxapine Capsules 25 mg due to cGMP violations that create a risk of cross-contamination.

    Product
    Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-05-30

    Mylan Recalls Loxapine Capsules Due to Cross-Contamination Risk

    Mylan Institutional, Inc. is recalling Loxapine Capsules 50 mg due to cGMP violations that create a risk of cross-contamination.

    Product
    Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
    Category
    Distribution
    0 states