FDA recall D-1331-2015

Product

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.

Reason for recall

Presence of Particulate Matter

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-03-18

Report date

2015-08-26

Termination date

2016-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockford, IL, United States

Primary source

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