Pine Pharmaceuticals Brilliant Blue G Intraocular Injection Vial Recall: Label Mix-Up
Pine Pharmaceuticals recalls Brilliant Blue G 0.5mL vials compounded by their company due to inaccurate labeling that could lead to incorrect product use.
Lower-risk recall
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Contact the company
What happened, in plain English
Pine Pharmaceuticals has recalled a specific vial of Brilliant Blue G for intraocular injection because the labeling was incorrect. This mix-up could lead to using the wrong product, which might cause harm if administered incorrectly. Read more at govinfonow.com/recall/40790-pine-pharmaceuticals-brilliant-blue-g-intraocular-injection-vial-recall-label.
Source Summary by GovInfoNow · govinfonow.com/recall/40790-pine-pharmaceuticals-brilliant-blue-g-intraocular-injection-vial-recall-label · Updated October 7, 2026 · FDA enforcement record: FDA #D-0607-2018
Cite this page
“Pine Pharmaceuticals Brilliant Blue G Intraocular Injection Vial Recall: Label Mix-Up.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40790-pine-pharmaceuticals-brilliant-blue-g-intraocular-injection-vial-recall-label. Based on FDA recall #D-0607-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0607-2018%22&limit=1).
Why it’s dangerous
The vial had an inaccurate auxiliary label that listed active/inactive ingredients for the wrong product. This mix-up could lead to using the incorrect medication during eye injections, potentially causing harm.
Who’s affected
Healthcare professionals who compounded or administered this specific vial for eye injections may be affected. Patients receiving the product from this recall are at risk if the wrong product was used.
How to tell if you have this one
Check for vials labeled 'Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL' compounded by Pine Pharmaceuticals at 355 Riverwalk Pkwy in Tonawanda, NY. The NDC code is 69194-0358-01 with lot number 18098@1 and expiration date 7/16/2018.
- Brand
Pine Pharmaceuticals- Category
Drug
What to do — step by step
Check Label
Verify the vial label for the correct product information and active ingredients.
Where it went and when
Where it was distributed
Distributed in New York.
FDA distribution: “NY only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA terminated this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates the labeling was incorrect, so it should not be used until the issue is resolved.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0607-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0607-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.