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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Category
- Drug — Compounded Injectable
- Affected units
- 8
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
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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