Mylan Pharmaceuticals Inc: Drug Recall

Recall #D-0845-2022 · 04/12/2022

Class I: Dangerous

Recall Details

Recall Number: D-0845-2022
Classification: Class I
Product Type: Drug
Recalling Firm: Mylan Pharmaceuticals Inc
Status: Terminated
Date Initiated: 04/12/2022
Location: Morgantown, WV, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 89,665 vials

Reason for Recall

Labeling: Missing label on the vial

Product Description

Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80

Distribution Pattern

USA nationwide.

Other Recalls by Mylan Pharmaceuticals Inc

Class II: Risk 02/25/2025

Failed Dissolution Specifications - low dissolution results
Class I: Dangerous 07/05/2022

Labeling: Missing label: Label missing from some prefilled pens.
Class II: Risk 04/07/2022

Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class II: Risk 04/01/2022

Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Class II: Risk 01/21/2022

cGMP deficiencies

View all recalls by Mylan Pharmaceuticals Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.