Recalls / Class I
Class ID-0845-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot #: BF21002800, Exp 8/2023
Why it was recalled
Labeling: Missing label on the vial
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3711 Collins Ferry Rd, Morgantown, West Virginia 26505-2362
Distribution
- Quantity
- 89,665 vials
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2022-04-12
- FDA classified
- 2022-05-04
- Posted by FDA
- 2022-05-04
- Terminated
- 2023-10-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0845-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.