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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Category
- Drug — Compounded Injectable
- Affected units
- 2
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
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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