Testosterone Cypionate Injectable Compounded Injection Lacks Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/Anastrozole 1.5mg/mL injectable due to lack of assurance of sterility. The product was distributed in the United States including Washington, D.C. and Puerto Rico.
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: The agency classified this as FDA Class II. Injectable medications with lack of sterility assurance pose risk of serious infections including sepsis and serious injury. Although no illnesses are reported in the source text, the Class II designation combined with the serious nature of potential microbial contamination in injectable products meets the threshold for Severe.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/Anastrozole 1.5mg/mL in oil injectable medication due to lack of assurance of sterility. This is a prescription-only compounded drug product.
The affected lots are: T1009092021:50 with Beyond Use Date 03/08/2022, and T1006302021:37 with Beyond Use Date 12/27/2021. A total of 6 vials were distributed.
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Consumers who have received this product should consult their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.5MG/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
- 6
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: T1009092021:50 BUD: 03/08/2022
- T1006302021:37 BUD: 12/27/2021
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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