The Recall Desk
SevereFDA (Drugs)·D-0180-2022·Announced 2021-11-17

Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/ml injectable due to lack of assurance of sterility. The product was distributed across the United States, including 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: This is an FDA Class II recall of a sterile injectable pharmaceutical product. Lack of sterility assurance in an injectable medication poses a significant risk of serious infection or other adverse health consequences, meeting the criteria for Severe classification.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/ml injectable in sesame oil due to lack of assurance of sterility. The recalled product is a prescription-only injectable medication distributed in vials.

The product was distributed across the United States, including Washington, D.C. and Puerto Rico. Multiple lot numbers are affected, with expiration dates ranging from October 2021 through March 2022.

Consumers who have received this product should contact their healthcare provider or pharmacist. Patients should not use the product and should consult with their medical professional regarding continuation of testosterone therapy through alternative sources.

The recalled product

Product
TESTOSTERONE CYPIONATE 200MG/ML INJ #2 IN SESAME 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 / Hormone
Hazard
  • sterility-assurance
  • contamination-risk
  • injection-infection-risk

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 (9)

  • Lot: T1007082021:20 BUD: 01/04/2022
  • T0907262021:21 BUD: 01/04/2022
  • T0506142021:81 BUD: 12/11/2021
  • T104142021:49 BUD: 10/11/2021
  • T1006022021:96 BUD: 11/29/2021
  • T0507152021:79 BUD: 01/11/2022
  • T1009082021:42 BUD: 03/07/2022
  • T0508172021:37 BUD: 02/13/2022
  • T0505112021:57 BUD: 10/11/2021

Distribution

Distribution scope not specified by the agency.

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