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.
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 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.
See all 20 products in this recall →Related recalls
Same manufacturer · Carolina Infusion
See all →- HighInjectable drug product recalled for lack of sterility assurance
FDA (Drugs) · 2022-09-21
- HighInjectable Steroid Product Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
- HighInjectable testosterone product recalled for sterility assurance defect
FDA (Drugs) · 2022-09-21
- HighInjectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
- HighSermorelin Acetate Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
Same hazard · contamination
See all →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02