Injectable drug product recalled for lack of sterility assurance
Carolina Infusion is recalling MIC/B12/L-Carn (HD) injectable vials due to inability to assure product sterility. The product was distributed nationwide.
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 for a risk-of-harm injectable product where sterility cannot be assured. No illnesses or injuries are reported in the source material, keeping the score at High rather than Severe per the rubric criterion for products without reported injury.
Plain-English summary
Carolina Infusion is recalling MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 mL vials, because the manufacturer cannot assure the sterility of the product.
The affected lots are: 05042022@4 (expiration 10/31/2022), 062920222@9 (expiration 12/26/2022), and 07262022@3 (expiration 01/22/2023). The product was distributed nationwide in the United States.
Lack of sterility assurance in injectable products poses a risk of serious infection. Patients who have received this product should contact their healthcare provider to discuss their individual situation and any appropriate follow-up care.
Anyone with unused product should stop use and consult with their pharmacy or healthcare provider.
The recalled product
- Product
- MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- contamination-risk
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 (3)
- Lots: 05042022@4 BUD: 10/31/2022
- 062920222@9 BUD: 12/26/2022
- 07262022@3 BUD: 01/22/2023
Distribution
Distributed nationwide across the United States.
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