FDA Recalls LipoLean Injectable Vials Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 433 vials of LipoLean injectable compounded in Florida due to a lack of assurance of sterility.
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: The recall is classified as FDA Class II, which involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard of sterility failure in an injectable product carries a significant risk of serious injury, such as infection, fitting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for 433 vials of LipoLean, an injectable compound containing inositol, choline, B-complex, leucine, carnitine, chromium, and lidocaine. The product was compounded by Wells Pharmacy Network LLC in Ocala, Florida, and distributed nationwide.
The recall is being conducted because of a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microorganisms, which poses a risk of infection if injected. The recall covers all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 04132016@32, 05062016@4, 05312016@5, 06132016@93, 06282016@36, and 08172016@5.
Consumers and healthcare providers who have this product should stop using it immediately and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial, Compounded by Wells Pharmacy. Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 433
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 (7)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 04132016@32
- 05062016@4
- 05312016@5
- 06132016@93
- 06282016@36
- 08172016@5.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 97 recalled by Wells Pharmacy Network LLC 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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