D-0845-2022 Class I Terminated
FDA drug recall D-0845-2022 was initiated by Mylan Pharmaceuticals Inc on Apr 12, 2022 and is designated Class I. Reason for recall: Labeling: Missing label on the vial The recall status is terminated (terminated Oct 18, 2023). Affected quantity: 89,665 vials.
Recall details
- Product Type
- Drugs
- Report Date
- May 4, 2022
- Initiation Date
- Apr 12, 2022
- Termination Date
- Oct 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89,665 vials
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
Reason for recall
Labeling: Missing label on the vial
Distribution pattern
USA nationwide.
Code information
Lot #: BF21002800, Exp 8/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0845-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026