Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance
Empower Pharmacy is recalling Testosterone Cypionate Injection due to lack of sterility assurance. The recall affects 8,230 vials nationwide; patients should not use affected lot #202364.
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 Class II recall of a compounded injectable drug with lack of sterility assurance. While no illnesses or injuries have been reported in the source text, non-sterile injectables pose a significant risk of serious infection and sepsis. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Empower Pharmacy is recalling Testosterone Cypionate Injection, 200 mg/mL, supplied as 5 mL sterile multiple-dose vials compounded on 08/20/2024 with a beyond-use date of 05/28/2025. The recalled product is lot #202364.
The recall was initiated because the product lacks assurance of sterility. Non-sterile injectable medications pose a serious risk of infection, including injection site infections and sepsis.
The recalled product was distributed nationwide. Approximately 8,230 vials of this lot were distributed.
Healthcare providers and patients who have received this product should consult their healthcare provider regarding potential exposure. Patients should not use any remaining vials of the recalled product (lot #202364).
The recalled product
- Product
- Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.
- Manufacturer
- Empower Clinic Services, LLC dba Empower Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- contamination
- infection
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)
- Lot #: 202364
- Exp 5/28/2025
Distribution
Distributed nationwide across the United States.
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