The Recall Desk

FDA (Drugs) recall action 89930

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalled 2 products on 2022-05-18

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
2022-05-18
Critical
0
Units
1,440

Why these products were recalled

Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

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

  • HighFDA (Drugs)··2022-05-18

    Esomeprazole magnesium delayed-release capsules recalled for impurity specification failure

    Mylan Institutional Inc. is recalling Esomeprazole Magnesium Delayed-Release Capsules 20 mg due to failed impurity specifications detected during stability testing. 555 cartons of affected lots were distributed nationwide.

    Product
    Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-05-18

    Esomeprazole Magnesium Delayed-Release Capsules Recalled for Failed Quality Specifications

    Mylan Institutional is recalling Esomeprazole Magnesium Delayed-Release Capsules 40 mg due to failed impurity specifications found during stability testing, affecting 885 cartons nationwide.

    Product
    Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
    Category
    Distribution
    0 states