D-1292-2022 Class I Terminated
FDA drug recall D-1292-2022 was initiated by Mylan Pharmaceuticals Inc on Jul 5, 2022 and is designated Class I. Reason for recall: Labeling: Missing label: Label missing from some prefilled pens. The recall status is terminated (terminated Feb 26, 2024). Affected quantity: 253,200 pens (50,650/5 per packs).
Recall details
- Product Type
- Drugs
- Report Date
- Aug 3, 2022
- Initiation Date
- Jul 5, 2022
- Termination Date
- Feb 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 253,200 pens (50,650/5 per packs)
Product description
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV
Reason for recall
Labeling: Missing label: Label missing from some prefilled pens.
Distribution pattern
Product was distributed nationwide within the United States
Code information
Lot #: BF21002895, Exp. Date Aug 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1292-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026