FDA recall D-918-2013

Product

Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA

Reason for recall

Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes

Distribution

FL, GA, IN, LA and SC.

Key facts

Status

Terminated

Initiation date

2013-03-11

Report date

2013-09-04

Termination date

2017-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Augusta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-918-2013