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.
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: 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
- Hazard
- sterility-failure
- 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 (1)
- Lot: 08172022@1 BUD: 09/16/2022
Distribution
Distributed nationwide across the United States.
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