Why it was recalled
Labeling: Missing label on the vial
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
Lot numbers, UPCs & expiration codes
Lot #: BF21002800, Exp 8/2023
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0845-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 12, 2022
- FDA report date
- May 4, 2022
- Quantity
- 89,665 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0845-2022, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 89970
- Address
- 3711 Collins Ferry Rd
- Code information
- Lot #: BF21002800, Exp 8/2023
- Postal code
- 26505-2362
- Report date
- May 4, 2022
- Product type
- Drugs
- Recall number
- D-0845-2022
- Classification
- Class I
- Recalling firm
- Mylan Pharmaceuticals Inc
- Product quantity
- 89,665 vials
- Termination date
- Oct 18, 2023
- Reason for recall
- Labeling: Missing label on the vial
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Apr 12, 2022
- Initial firm notification
- Press Release
- Center classification date
- May 4, 2022