Agency classClass IIOur severity:High FDA (Drugs)·D-1525-2022·Announced 2022-09-21

FDA Recalls Test Cypionate/Propionate Injectable for Lack of Sterility Assurance

Carolina Infusion is recalling TEST CYP/PROP 100 MG/100 MG/ML injectable vials due to lack of assurance of product sterility. Patients should contact their healthcare provider.

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 sterile injectable product where sterility cannot be assured—a risk-of-harm scenario. FDA Class II classification with no reported illnesses or injuries meets the High severity criterion per the rubric.

Plain-English summary

Carolina Infusion LLC is recalling TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable supplied in 12.6 mL vials. The recall is due to lack of assurance of sterility.

The affected lot is 07052022@1 with a beyond-use date of October 8, 2022. The product was distributed nationwide in the United States.

Patients who have used or possess affected lots should contact their healthcare provider immediately and discontinue use. Healthcare providers should report any adverse events to the FDA.

The recalled product

Product: TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Injectable
Hazard: lack-of-sterility
Affected units: 1

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: 07052022@1 BUD: 10/08/2022

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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