Agency classClass IIOur severity:High FDA (Drugs)·D-1519-2022·Announced 2022-09-21

Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance Concerns

Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider if they received this product.

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: This is an FDA Class II recall for a sterility assurance failure of an injectable drug product with no reported hospitalizations or illnesses. The product poses a risk of harm to patients if not sterile, fitting the rubric criterion for high-risk products where injury has not yet been reported.

Plain-English summary

Carolina Infusion LLC is recalling Semaglutide/Cyanocobalamin injectable syringes distributed nationwide in the USA. The affected lots are 08122022@8 (best-use-by 09/11/2022) and 08162022@3 (best-use-by 09/15/2022).

The recall is due to lack of assurance of sterility. Injectable medications must maintain strict sterility standards to be safe for administration.

Patients who received this product should contact their healthcare provider. Healthcare providers and dispensaries should stop dispensing the product and quarantine remaining stock. For additional information, contact the FDA.

The recalled product

Product: Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Injectable / Sterility
Hazard: sterility
infection-risk
Affected units: 24

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 (2)

Lots: 08122022@8 BUD: 09/11/2022
08162022@3 BUD: 09/15/2022

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 →

Same manufacturer · Carolina Infusion

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