Agency classClass IIOur severity:High FDA (Drugs)·D-1518-2022·Announced 2022-09-21

Sermorelin Acetate Injectable Recalled Due to Lack of Sterility Assurance

Carolina Infusion is recalling Sermorelin Acetate injectable (1 MG/ML, 9 ML syringes) distributed nationwide due to lack of assurance of sterility. The manufacturer could not adequately document that the product meets required sterility standards.

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 a high-risk product (injectable medication) with a confirmed manufacturing issue (lack of sterility assurance), but no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High.

Plain-English summary

Carolina Infusion is recalling Sermorelin Acetate 1 MG/ML Injectable supplied in 9 ML syringes due to lack of assurance of sterility. The affected lots are 08012022@14 (BUD 08/31/2022) and 08192022@7 (BUD 09/23/2022).

Injectable medications must meet strict sterility standards to be safe for use. This product does not have adequate documentation demonstrating that it meets those standards. The manufacturer could not provide sufficient assurance of the product's sterility.

The recalled product was distributed nationwide in the United States. Patients or healthcare facilities with this product should contact their pharmacist or healthcare provider. Consumers should not use the remaining product without consulting a healthcare professional.

The recalled product

Product: Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Injectable
Hazard: sterility-failure
contamination
Affected units: 8

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: 08012022@14 BUD: 08/31/2022
08192022@7 BUD: 09/23/2022

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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Same hazard · sterility failure