FDA recall D-0582-2016

Product

Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.

Reason for recall

Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-11-04

Report date

2016-01-27

Termination date

2017-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tonawanda, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0582-2016