The Recall Desk
SevereFDA (Drugs)·D-0098-2022·Announced 2021-11-17

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.

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 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
Manufacturer
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Category
Drug — Injectable / Compounded Pharmaceutical
Hazard
  • sterility-failure
  • 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 (1)

  • Lot: 08062021:30 BUD: 10/31/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category