Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance Concerns
Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider if they received this product.
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 sterility assurance failure of an injectable drug product with no reported hospitalizations or illnesses. The product poses a risk of harm to patients if not sterile, fitting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Carolina Infusion LLC is recalling Semaglutide/Cyanocobalamin injectable syringes distributed nationwide in the USA. The affected lots are 08122022@8 (best-use-by 09/11/2022) and 08162022@3 (best-use-by 09/15/2022).
The recall is due to lack of assurance of sterility. Injectable medications must maintain strict sterility standards to be safe for administration.
Patients who received this product should contact their healthcare provider. Healthcare providers and dispensaries should stop dispensing the product and quarantine remaining stock. For additional information, contact the FDA.
The recalled product
- Product
- Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable / Sterility
- Hazard
- sterility
- infection-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 (2)
- Lots: 08122022@8 BUD: 09/11/2022
- 08162022@3 BUD: 09/15/2022
Distribution
Distributed nationwide across the United States.
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