FDA-Drug2015-08-26Class I

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.

Mylan Institutional LLC
Hazard

Presence of Particulate Matter

Sold states
Nationwide
Affected count
4,445 vials
Manufactured in
4901 Hiawatha Dr, Rockford, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1331-2015

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