Injectable Steroid Product Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling its TEST CYP/DHEA injectable steroid vials nationwide because the manufacturer cannot assure they are sterile. The recall affects 348 vials with lot numbers from June-August 2022.
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 an FDA Class II recall without reported illnesses or injuries. The hazard—lack of sterility assurance in an injectable product—is a risk-of-harm situation where injury has not yet been reported, meeting the criteria for a High severity score per the rubric.
Plain-English summary
Carolina Infusion LLC is recalling TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 mL vials, due to lack of assurance of sterility. A total of 348 vials distributed nationwide are affected.
The affected products include multiple lot codes manufactured between June and August 2022, with beyond-use dates between August and November 2022. The FDA has classified this as a Class II recall.
Sterility is a required quality standard for injectable products. This recall indicates the manufacturer cannot assure that the product meets the FDA's sterility requirements.
The recalled product
- Product
- TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable Steroid
- Hazard
- sterility-defect
- infection-risk
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 (20)
- Lots: 06012022@1
- 06012022@2 BUD: 08/30/2022
- 06032022@1
- 06032022@2
- 06032022@13 BUD: 09/01/2022
- 06062022@7
- BUD: 09/04/2022
- 06072022@3
- 06072022@4 BUD: 09/05/2022
- 06082022@1
- 06082022@2
- 06082022@4 BUD: 09/06/2022
- 06102022@8
- BUD: 09/08/2022
- 09/11/2022
- 06132022@1
- 06132022@7
- 06132022@14
- 06132022@15
- BUD: 09/11/2022
Distribution
Distributed nationwide across the United States.
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