FDA recall D-1412-2019

Product

Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0.

Reason for recall

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-06-18

Report date

2019-07-03

Termination date

2021-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weeki Wachee, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1412-2019