Why it was recalled
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Product description
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.
Lot numbers, UPCs & expiration codes
Batch # BF20003118, Exp. August 2022
Where it was sold
Nationwide in the USA and Thailand.
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-0462-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 5, 2022
- FDA report date
- Jan 26, 2022
- Quantity
- 73,175 prefilled pens
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0462-2022, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 89357
- Address
- 3711 Collins Ferry Rd
- Code information
- Batch # BF20003118, Exp. August 2022
- Postal code
- 26505-2362
- Report date
- Jan 26, 2022
- Product type
- Drugs
- Recall number
- D-0462-2022
- Classification
- Class I
- Recalling firm
- Mylan Pharmaceuticals Inc
- Product quantity
- 73,175 prefilled pens
- Termination date
- Jan 12, 2024
- Reason for recall
- Labeling: Missing Label: label missing from some Semglee prefilled pens.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Thailand.
- Recall initiation date
- Jan 5, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 28, 2022