The Recall Desk
SevereFDA (Drugs)·D-0170-2022·Announced 2021-11-17

Testosterone Cypionate and Anastrozole Injectable Recalled for Lack of Sterility Assurance

Vita Pharmacy (Talon Compounding Pharmacy) is recalling testosterone cypionate 200mg/anastrozole 0.25mg/mL injectable in oil due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.

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: The source indicates FDA Class II classification. Injectable products with lack of sterility assurance carry substantial risk of serious infection or sepsis if used by patients. Although no illnesses are reported in the source, Class II designation with a non-sterile injectable product meets the "Severe" threshold per the rubric.

Plain-English summary

Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy (located at 2950 Thousand Oaks Drive, Suite 25, San Antonio, Texas 78247), is recalling testosterone cypionate 200mg/anastrozole 0.25mg/mL in oil injectable (prescription only) due to lack of assurance of sterility.

The affected product was distributed across the United States, including Washington, D.C. and Puerto Rico. The recalled lots are T1006092021:18 (beyond-use date 12/06/2021) and T1009022021:89 (beyond-use date 03/01/2022). A total of 4 vials are affected.

Patients who have received this product should consult their healthcare provider immediately. Do not use the product. Contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy at 2950 Thousand Oaks Drive, Suite 25, San Antonio, Texas 78247 or contact the FDA if you have any questions.

The recalled product

Product
TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.25MG/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 — Injectable / Compounded
Hazard
  • lack-of-sterility
  • injectable-contamination

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: T1006092021:18 BUD: 12/06/2021
  • T1009022021:89 BUD: 03/01/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category