SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on do
Summary
The FDA issued a Class II for SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage by Carolina Infusion, LLC. Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product..
Details
Source
Drug Recall
External ID
D-0019-2027
Action Date
2026-10-14
Status
Ongoing
Category
drug
Product Description
SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Lot/Code Info: Lot: 07282026@3, BUD: 9/11/2026; 08252026@9, BUD: 10/9/2026; 08042026@12, BUD: 9/18/2026; 08072026@15, BUD: 9/21/2026.
Quantity Affected: 57.0 mls - in patient specific syringe doses
Reason for Recall
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Distribution
Nationwide within the U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-10
Company
Ridgeland, SC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 67 drug-related FDA actions this month.
Carolina Infusion, LLC has 16 FDA actions in our database, including 16 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Carolina Infusion, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Carolina Infusion, LLC have FDA actions?
Carolina Infusion, LLC has 16 FDA actions in our database, including 16 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0019-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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