FDA recall D-66318-001

Product

Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.

Reason for recall

Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.

Distribution

Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.

Key facts

Status

Terminated

Initiation date

2013-09-17

Report date

2013-11-13

Termination date

2014-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Thousand Oaks, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66318-001