Mylan Institutional LLC recalls CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: M…

Recall date

March 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1331-2015

FDA classification

Class I

Brand / firm

Mylan Institutional LLC

Sold / distributed

Nationwide

Why it was recalled

Presence of Particulate Matter

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.