The Recall Desk
SevereFDA (Drugs)·D-0148-2022·Announced 2021-11-17

Ultra-Test Injectable Compounded Drug Recalled for Lack of Sterility Assurance

Talon Compounding Pharmacy is recalling Ultra-Test (CYP 80%/PROP 20%) 200mg/ml injectable across the United States, Puerto Rico, and Washington, D.C. due to lack of assurance of sterility.

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 recall is classified as FDA Class II. Lack of sterility assurance in an injectable pharmaceutical product presents a direct risk of serious infection and potential hospitalization, meeting the criteria for a Severe rating under the Class II with significant risk of harm standard.

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 Ultra-Test (CYP 80%/PROP 20%) 200mg/ml injectable due to lack of assurance of sterility.

The product is a compounded prescription injectable. A total of 23 vials are subject to this recall, distributed across the United States including Washington, D.C. and Puerto Rico. The affected lots and expiration dates are: T1008032021:86 (BUD 01/30/2022); T1004192021:25 (BUD 10/16/2021); T1005252021:33 (BUD 11/21/2021); and T1009082021:96 (BUD 03/07/2022).

Patients who have received this product should contact their physician or healthcare provider. Healthcare providers and patients with questions about this recall are advised to contact the recalling firm or the FDA.

The recalled product

Product
ULTRA-TEST (CYP 80%/PROP 20%) 200MG/ML INJ #1 200MG/ML 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 — Compounded Injectable
Hazard
  • lack-of-sterility-assurance
  • injection-contamination-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 (4)

  • Lot: T1008032021:86 BUD: 01/30/2022
  • T1004192021:25 BUD: 10/16/2021
  • T1005252021:33 BUD: 11/21/2021
  • T1009082021:96 BUD: 03/07/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category