Mylan Pharmaceuticals Inc: Drug Recall

Recall #D-0462-2022 · 01/05/2022

Class I: Dangerous

Recall Details

Recall Number: D-0462-2022
Classification: Class I
Product Type: Drug
Recalling Firm: Mylan Pharmaceuticals Inc
Status: Terminated
Date Initiated: 01/05/2022
Location: Morgantown, WV, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 73,175 prefilled pens

Reason for Recall

Labeling: Missing Label: label missing from some Semglee prefilled pens.

Product Description

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.

Distribution Pattern

Nationwide in the USA and Thailand.

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 I: Dangerous 04/12/2022

Labeling: Missing label on the vial
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.

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.