Recalls / Class I
Class ID-1059-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot #: APB032, APB033, Exp. April 2019
Why it was recalled
Presence of Particulate Matter: particulate matter identified as copper salts
Recalling firm
- Firm
- Mylan Institutional Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4951 Hiawatha Dr, N/A, Rockford, Illinois 61103-1287
Distribution
- Quantity
- 11,964 cartons of 30 vials
- Distribution pattern
- Nationwide in the United States
Timeline
- Recall initiated
- 2019-02-01
- FDA classified
- 2019-03-26
- Posted by FDA
- 2019-03-20
- Terminated
- 2020-06-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1059-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.