FDA Recall D-0845-2022
Mylan Pharmaceuticals Inc · Morgantown, WV
Class I — life-threatening Terminated 554 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Reason for recall
Labeling: Missing label on the vial
Recall record
- Recall number
D-0845-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- USA nationwide.
- Recall initiated
- 2022-04-12
- Classified by FDA Center
- 2022-05-04
- FDA published
- 2022-05-04
- Terminated
- 2023-10-18
- Recalling firm
- Mylan Pharmaceuticals Inc
- Firm location
- Morgantown, WV