Why it was recalled
Labeling: Missing label: Label missing from some prefilled pens.
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
Lot numbers, UPCs & expiration codes
Lot #: BF21002895, Exp. Date Aug 2023
Where it was sold
Product was distributed nationwide within the United States
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-1292-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 5, 2022
- FDA report date
- Aug 3, 2022
- Quantity
- 253,200 pens (50,650/5 per packs)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1292-2022, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 90545
- Address
- 5005 Greenbag Rd
- Code information
- Lot #: BF21002895, Exp. Date Aug 2023
- Postal code
- 26501-7124
- Report date
- Aug 3, 2022
- Product type
- Drugs
- Recall number
- D-1292-2022
- Classification
- Class I
- Recalling firm
- Mylan Pharmaceuticals Inc
- Product quantity
- 253,200 pens (50,650/5 per packs)
- Termination date
- Feb 26, 2024
- Reason for recall
- Labeling: Missing label: Label missing from some prefilled pens.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed nationwide within the United States
- Recall initiation date
- Jul 5, 2022
- Initial firm notification
- Press Release
- Center classification date
- Jul 26, 2022