Compounded sterile drug solution recalled due to manufacturing sterility failure
Vital Care Compounder is recalling Brilliant Blue G Solution due to inability to assure product sterility. The recall involves 86 vials (Lot 60448) distributed in Alabama, Louisiana, Mississippi, and Tennessee.
What this means for you
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: This is an FDA Class II recall of a compounded sterile drug product where the manufacturing process cannot assure sterility. Since no illnesses or injuries are reported in the source material, this meets the rubric criterion for Score 3 (High): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vital Care Compounder, located in Hattiesburg, Mississippi, is recalling Brilliant Blue G 0.04% Solution supplied in 2 mL vials. The product is a compounded sterile pharmaceutical preparation intended for prescription use.
The FDA conducted an inspection of the manufacturing facility and determined that the production process cannot guarantee the sterility of products. The affected lot is Lot 60448 with a beyond-use date of October 31, 2022.
The recall affects 86 vials that were distributed to patients and healthcare facilities in Alabama, Louisiana, Mississippi, and Tennessee. Individuals in possession of the recalled product should discontinue use and consult their healthcare provider or contact the manufacturer for guidance.
The recalled product
- Product
- BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Hazard
- sterility-assurance-failure
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 (1)
- Lot: 60448 BUD: 10/31/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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