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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pine Pharmaceuticals, LLC: Brilliant Blue G Recalled Due to Incorrect Ingredient Labeling

Agency Publication Date: March 22, 2018
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Summary

Pine Pharmaceuticals is recalling 136 units of Brilliant Blue G for Intraocular Injection (0.25 mg/mL) after discovering a labeling mix-up. The medication vials were labeled with an inaccurate auxiliary label that lists active and inactive ingredients meant for an entirely different product. This recall affects products sold exclusively in New York that were distributed in 0.5mL vials.

Risk

The presence of an incorrect ingredient label could lead to medical errors if healthcare providers rely on the inaccurate information during patient care. While the medication inside the vial is correct, the auxiliary label describes the wrong chemical components, potentially leading to confusion regarding the drug's composition.

What You Should Do

  1. Check your medication vials for Brilliant Blue G for Intraocular Injection (0.5mL vial, 0.25 mg/mL) with the National Drug Code (NDC) 69194-0358-01.
  2. Identify affected products by looking for Lot#: 18098@1 or Lot#: 18098 with an expiration date of 7/16/2018.
  3. If you have this product, stop using it immediately and set it aside to ensure it is not administered to patients.
  4. Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and any concerns about previous treatments.
  5. Return any unused vials to the place of purchase for a refund and contact Pine Pharmaceuticals at 100 Colvin Woods Pkwy, Tonawanda, NY to report any issues.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Product return and pharmacist consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Brilliant Blue G for Intraocular Injection (0.5mL)
Model:
NDC 69194-0358-01
Recall #: D-0607-2018
Lot Numbers:
18098@1 (Exp. 7/16/2018)
18098
Date Ranges: Exp. 7/16/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79457
Status: Resolved
Manufacturer: Pine Pharmaceuticals, LLC
Manufactured In: United States
Units Affected: 136 units
Distributed To: New York

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.