Brilliant Blue G Injection (Leiter's) – sterility risk (2016)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35
Brand
Leiter's Compounding
Lot Codes / Batch Numbers
All unexpired lots, Expirations dates of .09/20/2016 to 10/10/2016
Products Sold
All unexpired lots; Expirations dates of .09/20/2016 to 10/10/2016
Leiter's Compounding is recalling Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preser due to Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026