FDA Recall D-1292-2022
Mylan Pharmaceuticals Inc · Morgantown, WV
Class I — life-threatening Terminated 601 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), 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.
Recall record
- Recall number
D-1292-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Product was distributed nationwide within the United States
- Recall initiated
- 2022-07-05
- Classified by FDA Center
- 2022-07-26
- FDA published
- 2022-08-03
- Terminated
- 2024-02-26
- Recalling firm
- Mylan Pharmaceuticals Inc
- Firm location
- Morgantown, WV