FDA recall D-0607-2018

Product

Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01

Reason for recall

Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.

Distribution

NY only

Key facts

Status

Terminated

Initiation date

2018-03-05

Report date

2018-03-28

Termination date

2018-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tonawanda, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0607-2018