Testosterone Cypionate-Propionate Compounded Injectable Recalled for Sterility Assurance Deficiency
New Vitalis Pharmacy is recalling its Testosterone Cypionate-Propionate injectable medication due to lack of assurance of sterility. The recall affects 102 vials distributed nationwide.
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: Lack of sterility assurance in an injectable medication constitutes risk-of-harm per the rubric. The FDA Class II classification and absence of reported illnesses or injuries support a High (3) severity score.
Plain-English summary
New Vitalis Pharmacy is recalling Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, a compounded injectable medication for intramuscular use only, due to lack of assurance of sterility.
The recall affects 102 vials across two lots: Lot #AL-05222023@901 with a beyond-use date of July 22, 2023, and Lot #AL-06122023@908CS with a beyond-use date of August 11, 2023. These vials were distributed nationwide.
Injectables without assured sterility pose a risk of bacterial infection. This is classified as an FDA Class II recall.
The recalled product
- Product
- Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
- Manufacturer
- New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
- Category
- Drug — Compounded 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 (4)
- Lot #: AL-05222023@901
- BUD 7/22/23
- AL-06122023@908CS
- BUD 8/11/23
Distribution
Distributed nationwide across the United States.
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