Why it was recalled
Presence of Particulate Matter: particulate matter identified as copper salts
Product description
Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30
Lot numbers, UPCs & expiration codes
Lot #: APB032, APB033, Exp. April 2019
Where it was sold
Nationwide in 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-1059-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 1, 2019
- FDA report date
- Mar 20, 2019
- Quantity
- 11,964 cartons of 30 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional Inc
Original FDA data
Every field from FDA enforcement report D-1059-2019, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 82210
- Address
- 4951 Hiawatha Dr
- Code information
- Lot #: APB032, APB033, Exp. April 2019
- Postal code
- 61103-1287
- Report date
- Mar 20, 2019
- Product type
- Drugs
- Recall number
- D-1059-2019
- Classification
- Class I
- Recalling firm
- Mylan Institutional Inc
- Product quantity
- 11,964 cartons of 30 vials
- Termination date
- Jun 19, 2020
- Reason for recall
- Presence of Particulate Matter: particulate matter identified as copper salts
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30
- Distribution pattern
- Nationwide in the United States
- Recall initiation date
- Feb 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 26, 2019