Drug product
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
D-1059-2019
Product summary
- Event
- Event 82210
- Status
- Terminated
- Classification
- Class I
- Quantity
- 11,964 cartons of 30 vials
- Official record key
drug-enforcement:D-1059-2019
Official wording
Reason: Presence of Particulate Matter: particulate matter identified as copper salts
Code information: Lot #: APB032, APB033, Exp. April 2019
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter