FDA Recall D-0462-2022
Mylan Pharmaceuticals Inc · Morgantown, WV
Class I — life-threatening Terminated 737 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Reason for recall
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Recall record
- Recall number
D-0462-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA and Thailand.
- Recall initiated
- 2022-01-05
- Classified by FDA Center
- 2022-01-28
- FDA published
- 2022-01-26
- Terminated
- 2024-01-12
- Recalling firm
- Mylan Pharmaceuticals Inc
- Firm location
- Morgantown, WV