Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Failure
Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients using Lot 08172022@1 should contact their healthcare provider immediately.
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 for sterility assurance failure on an injectable medication. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the Score 3 (High) criterion.
Plain-English summary
Carolina Infusion LLC is recalling Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable in 0.4 ML syringes due to a lack of assurance of sterility. This is an FDA Class II recall.
The affected product is Lot 08172022@1 with a beyond-use date of 09/16/2022. The medication was distributed nationwide across the United States and is available by prescription only.
Patients currently using this medication should contact their healthcare provider immediately. Do not discontinue use without medical guidance. Return the product to your pharmacy or the manufacturer. Healthcare providers should stop dispensing this lot and notify patients who may have received it.
The recalled product
- Product
- Semaglutide/Cyanocobalamin 24/2 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 / Compounded
- 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: 08172022@1 BUD: 09/16/2022
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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