The Recall Desk
SevereFDA (Drugs)·D-0108-2022·Announced 2021-11-17

Compounded Injectable Injection Recalled for Lack of Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Blue Tree Lipo Extreme injectable (with Methylcobalamin) due to lack of assurance of sterility. The product was distributed in the United States.

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 drug recall involving a compounded injectable product with lack of sterility assurance. Compromised sterility in injectables presents a significant risk of serious adverse health effects including infection, and is classified by FDA as a Class II recall, which per the severity rubric merits a score of 4 where there is no reported hospitalization or illness data.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Blue Tree Lipo Extreme (with Methylcobalamin) injectable medication, Rx 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 product is Lot 09172021:87 with a Beyond Use Date of 12/16/2021. A total of 8 vials are subject to this recall.

Patients who have received this medication should consult with their healthcare provider. Consumers should not use this product and should contact their pharmacy for guidance on what to do with any vials they may have received.

The recalled product

Product
BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION 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
  • 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 (1)

  • Lot: 09172021:87 BUD: 12/16/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category