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

FDA recall notice · announced March 20, 2019 · Mylan Institutional

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Reason for recall

Presence of Particulate Matter: particulate matter identified as copper salts

Notes

Distribution: Nationwide in the United States
Lot/code information: Lot #: APB032, APB033, Exp. April 2019
Quantity: 11,964 cartons of 30 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.