FDA recall D-66200-001

Product

Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110.

Reason for recall

Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.

Distribution

NY & ME

Key facts

Status

Terminated

Initiation date

2013-09-05

Report date

2013-11-06

Termination date

2017-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Latham, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66200-001