Carolina Infusion Semaglutide/Cyanocobalamin Injectable Recalled for Sterility Issue
Carolina Infusion is recalling Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable syringes nationwide due to lack of sterility assurance. The affected lot 08152022@14 has a best-by date of September 14, 2022.
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: FDA Class II recall of an injectable medication with theoretical sterility risk and no reported illnesses or injuries. Qualifies as a risk-of-harm product without reported injury per the rubric.
Plain-English summary
Carolina Infusion LLC is recalling Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 mL syringe product because the manufacturer cannot assure that the product meets required sterility standards for injectable medications.
The affected product was distributed nationwide in the United States. The recalled lot is 08152022@14 with a best-by date of September 14, 2022.
Patients who have received this injectable should verify their lot number. Those in possession of product from lot 08152022@14 should not use it and should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable / Combination
- Hazard
- Affected units
- 4
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: 08152022@14 BUD: 09/14/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Carolina Infusion 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.
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