The Recall Desk
SevereFDA (Drugs)·D-0182-2022·Announced 2021-11-17

Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 25mg/mL Injectable due to lack of assurance of sterility. The product was distributed in 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 an injectable pharmaceutical product. Lack of sterility assurance in injectable medication represents a significant risk of harm because contaminated injectables can cause serious infection. Although no illnesses are reported in the source text, sterile injectable products are high-risk, and the agency's Class II classification for this type of defect warrants a Severe rating per the rubric.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 25mg/mL Injectable in Ethyl Oleate (prescription-only) due to lack of assurance of sterility. The recalled product was distributed across the United States, including Washington, D.C. and Puerto Rico.

The affected lots are: T0508192021:06 (BUD 02/15/2022); T0507022021:91 (BUD 12/29/2021); T0507192021:13 (BUD 01/15/2022); T0504262021:71 (BUD 10/23/2021); and T0509172021:03 (BUD 03/16/2022). The product was supplied as 16 vials per unit by Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.

Consumers who have received this product should consult their healthcare provider or pharmacist regarding the recall and any further instructions. The FDA classifies this as a Class II recall.

The recalled product

Product
TESTOSTERONE CYPIONATE 25MG/ML INJ #1 IN ETHYL OLEATE 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 Pharmaceutical
Hazard
  • sterility-failure
  • injection-contamination
  • 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 (5)

  • Lot: T0508192021:06 BUD: 02/15/2022
  • T0507022021:91 BUD: 12/29/2021
  • T0507192021:13 BUD: 01/15/2022
  • T0504262021:71 BUD: 10/23/2021
  • T0509172021:03 BUD: 03/16/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

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