Vital Care Compounder Recalls Brilliant Blue G Injection Vials
Vital Care Compounder is recalling 9 vials of Brilliant Blue G injection due to a defect in the aluminum crimps that may compromise sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile injection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Vital Care Compounder is recalling 9 vials of Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial. The recall is due to a lack of assurance of sterility, as the aluminum crimps do not fully seal the rubber stopper to the vials.
The affected product is identified by Lot #395575 with a use-by date of 07-27-2016. The product was distributed in Mississippi. No illnesses or injuries have been reported in the source text.
Consumers should stop using the product and contact Vital Care Compounder for further instructions or a refund.
The recalled product
- Product
- Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS
- Manufacturer
- Vital Care Compounder
- Category
- Drug — Injectable
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 395575
- Use by 07-27-2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Vital Care Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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