D-1059-2019 Class I Terminated
FDA drug recall D-1059-2019 was initiated by Mylan Institutional Inc on Feb 1, 2019 and is designated Class I. Reason for recall: Presence of Particulate Matter: particulate matter identified as copper salts The recall status is terminated (terminated Jun 19, 2020). Affected quantity: 11,964 cartons of 30 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 20, 2019
- Initiation Date
- Feb 1, 2019
- Termination Date
- Jun 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,964 cartons of 30 vials
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
Reason for Recall
Presence of Particulate Matter: particulate matter identified as copper salts
Distribution Pattern
Nationwide in the United States
Code Information
Lot #: APB032, APB033, Exp. April 2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1059-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026