Brilliant Blue G BBG recalled over sterility concerns
- Recall date
- June 10, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Vital Care Compounder recalls Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS
- Recall number
- D-1055-2016
- FDA classification
- Class II
- Brand / firm
- Vital Care Compounder
- Sold / distributed
- MS
Why it was recalled
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS
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