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
Reported: March 20, 2019 Initiated: February 1, 2019 #D-1059-2019
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
Details
- Recalling Firm
- Mylan Institutional Inc
- Units Affected
- 11,964 cartons of 30 vials
- Distribution
- Nationwide in the United States
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mylan Institutional Inc. Units affected: 11,964 cartons of 30 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: particulate matter identified as copper salts
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2019. Severity: Critical. Recall number: D-1059-2019.
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