Agency classClass IIOur severity:High FDA (Drugs)·D-1523-2022·Announced 2022-09-21

Carolina Infusion Injectable Hormones Recalled Due to Sterility Concerns

Carolina Infusion is recalling TEST CYP/DHEA injectable hormone products due to lack of sterility assurance. The recall affects nationwide distribution of 3 ML and 6 ML vials.

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: FDA Class II recall for lack of sterility assurance in an injectable product represents a risk-of-harm situation with no reported illnesses or injuries, meeting the High severity criterion.

Plain-English summary

Carolina Infusion LLC is recalling TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML injectable hormone products in 3 ML and 6 ML vials due to lack of assurance of sterility. The affected product lots are 07182022@9 (with an expiration date of 10/16/2022) and 07272022@15 (with an expiration date of 10/25/2022).

The FDA classified this as a Class II recall because the company cannot ensure the product meets sterility requirements. This injectable product is distributed nationwide as a prescription-only medication.

If you have received this product, consult with your healthcare provider immediately. Do not use these specific lots. Healthcare providers should remove affected inventory from stock and contact patients who may have received the affected product. The manufacturer is located at 95 Bees Creek Road, Ridgeland, SC 29936.

The recalled product

Product: TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Injectable / Hormone
Hazard: lack-of-sterility
contamination
Affected units: 3

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: 07182022@9 BUD: 10/16/2022
07272022@15 BUD: 10/25/2022

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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