FDA Drug recall D-1059-2019
Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL…
- FDA Drug
- Class I
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class I recall of Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL… by Mylan Institutional, citing presence of Particulate Matter: particulate matter identified as copper salts.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1059-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-02-01 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Institutional |
| Distribution | US |
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
Presence of Particulate Matter: particulate matter identified as copper salts
Identifiers
| code_info | Lot #: APB032, APB033, Exp. April 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1059-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.