FDA recall D-1484-2020

Mylan Institutional LLC · Class I · drug

Product

Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50

Reason for recall

Presence of Particulate Matter

Distribution

USA Nationwide

Key facts

Status
Terminated
Initiation date
2020-07-07
Report date
2020-08-12
Termination date
2023-01-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1484-2020