Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brilliant Blue Ophthalmic PF INJ Recalled by Premier Pharmacy Labs Inc Due to Lack of Assurance of Sterility: FDA inspection found...

Date: June 18, 2019
Company: Premier Pharmacy Labs Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Premier Pharmacy Labs Inc directly.

Affected Products

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.

Quantity: 578 vials

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Premier Pharmacy Labs Inc

Premier Pharmacy Labs Inc has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report