Injectable Steroid Compound Recalled Due to Sterility Assurance Failure
Talon Compounding Pharmacy is recalling a testosterone cypionate combination injectable product distributed nationwide due to lack of assurance of sterility, which could pose risk of serious infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of an injectable drug product with a direct risk of serious harm (infection from non-sterile injection). FDA Class II recalls with significant risk of serious infection or injury are classified as Severe per the rubric.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE (Lot T1009132021:38, BUD 03/12/2022) because the product lacks assurance of sterility.
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Injection of a non-sterile product poses the risk of serious infection. Patients who have received this product should contact their healthcare provider immediately for evaluation and guidance.
Consumers with questions about this recall should contact Talon Compounding Pharmacy at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.
The recalled product
- Product
- TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-failure
- 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 (1)
- Lot: T1009132021:38 BUD: 03/12/2022
Distribution
Distribution scope not specified by the agency.
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