The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

Same category