Testosterone Cypionate Anastrozole Injectable Recalled for Sterility Concerns
Talon Compounding Pharmacy is recalling a testosterone cypionate and anastrozole injectable product due to lack of assurance of sterility. The recall affects nine vials distributed across the United States.
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 pharmaceutical product. Lack of sterility assurance in injectable medications presents a significant risk of serious infection and harm; the product is a prescription injectable that directly enters the body, making any sterility failure a serious patient safety concern.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/Anastrozole 0.5mg/mL Injectable in sesame oil. The product is being recalled because the manufacturer cannot assure the sterility of the injectable medication.
The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. The affected lots are: Lot T1004132021:95 with expiration date 10/10/2021; Lot T1006162021:63 with expiration date 12/13/2021; and Lot T1004282021:19 with expiration date 10/25/2021. A total of 9 vials have been recalled.
Patients who have received this medication should consult with their healthcare provider immediately. Healthcare providers should quarantine remaining product and verify patient exposure.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 9
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 (3)
- Lot: T1004132021:95 BUD: 10/10/2021
- T1006162021:63 BUD: 12/13/2021
- T1004282021:19 BUD: 10/25/2021
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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