Injectable Diet Aid Product Recalled for Sterility Assurance Failure
Talon Compounding Pharmacy is recalling Well's Lipo-Lean injectable vials (Lot 08062021:30) due to lack of assurance of sterility. The product is distributed across the United States, Washington D.C., and Puerto Rico.
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 recall involving a sterility failure in an injectable drug product. Lack of sterility assurance in injectables presents significant risk of serious infection, which aligns with the Severe category criterion for Class II recalls with potential for serious health consequences.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling Well's Lipo-Lean injectable product containing inositol, choline, B-complex vitamins, leucine, carnitine, chromium, and lidocaine. The product is supplied in 2-vial packs and is available by prescription only.
The recall is being issued because the manufacturer cannot assure the sterility of the product. Lack of sterility in injectable products poses a risk of infection to patients who receive injections.
The affected product is distributed throughout the United States, including Washington D.C. and Puerto Rico. The specific lot number is 08062021:30, with a beyond-use date of October 31, 2021. Patients who have received injections from this product should consult their healthcare provider if they experience signs of infection.
The recalled product
- Product
- (WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 2
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: 08062021:30 BUD: 10/31/2021
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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