Testosterone Cypionate and Anastrozole Injectable Recall Due to Sterility Assurance Lack
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 200mg/anastrozole 1mg/ml injectable vials distributed across the United States, Puerto Rico, and Washington, D.C. 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 involving lack of sterility assurance for an injectable pharmaceutical product. Injectable products without sterile assurance represent a serious risk of infection and other harm, placing this recall in the Severe category per the rubric criteria for Class II recalls with significant injury risk.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 200mg/anastrozole 1mg/ml injectable vials (334 vials total) distributed across the United States, including Puerto Rico and Washington, D.C. The recall was initiated because there is a lack of assurance of sterility for this prescription-only injectable product.
The affected product was distributed in multiple lots with varying beyond-use dates (BUD) ranging from October 2021 through March 2022. The specific lot numbers and corresponding BUD dates are: T1006042021:60 (12/01/2021); T1008302021:63 (02/26/2022); T1005122021:36 (11/08/2021); T1007142021:23 (01/10/2022); T1008192021:94 (02/15/2022); 04202021:80 (10/17/2021); T1007012021:31 (12/28/2021); T1009092021:97 (03/08/2022); T1004092021:79 (10/06/2021); T1005242021:08 (11/20/2021); T1008092021:82 (02/05/2022); T1005042021:92 (10/31/2021); T1007262021:03 (01/22/2022); and T1006172021:47 (12/14/2021).
Patients currently using this product should contact their healthcare provider or pharmacist. Individuals who have received injections from these lots should consult a healthcare professional regarding potential health risks associated with the use of a non-sterile injectable product.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 334
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 (14)
- Lot: T1006042021:60 BUD: 12/01/2021
- T1008302021:63 BUD: 02/26/2022
- T1005122021:36 BUD: 11/08/2021
- T1007142021:23 BUD: 01/10/2022
- T1008192021:94 BUD: 02/15/2022
- 04202021:80 BUD: 10/17/2021
- T1007012021:31 BUD: 12/28/2021
- T1009092021:97 BUD: 03/08/2022
- T1004092021:79 BUD: 10/06/2021
- T1005242021:08 BUD: 11/20/2021
- T1008092021:82 BUD: 02/05/2022
- T1005042021:92 BUD: 10/31/2021
- T1007262021:03 BUD: 01/22/2022
- T1006172021:47 BUD: 12/14/2021
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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