Compounded Injectable Steroids Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility.
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 a sterile injectable compounded drug product. Lack of sterility assurance in injectable products poses a direct risk of serious infection and requires hospitalization if contamination occurs, meeting the Class II with significant injury-risk criterion.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Anastrozole 0.25mg/Dutasteride 1mg/ml in Oil Injectable (Rx only) distributed in the United States including Washington, D.C. and Puerto Rico. The recall was issued because there is a lack of assurance of sterility for the product.
Lot T1006032021:64 with a beyond-use date of 11/30/2021 is affected by this recall. The product was supplied in 2-vial containers.
Consumers who have received this product should discontinue use and consult their healthcare provider. Healthcare providers and patients are encouraged to report any adverse effects to the FDA.
The recalled product
- Product
- TEST CYPIONATE 200MG/ANASTROZOLE 0.25MG/DUTASTERIDE 1MG/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-assurance
- contamination-risk
- 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: T1006032021:64 BUD: 11/30/2021
Distribution
Distribution scope not specified by the agency.
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