Wells Pharmacy Recalls Leucine/Isoleucine/Valine Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 189 vials of Leucine/Isoleucine/Valine Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
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. According to the rubric, FDA Class II recalls involving potential hospitalization or significant injury risks are categorized as Severe (Score 4).
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling 189 vials of Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial. The recall is being conducted due to a lack of assurance of sterility in the compounded product.
The affected product was prepared between February 22, 2016, and September 14, 2016, and is within its expiry date. Specific lot codes identified include 04062016@3, 04252016@4, 05172016@4, 06162016@6, and 07212016@8. The recall covers all lot codes of the product prepared during this period.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for these specific lot codes and discontinue use of the affected vials. The FDA has classified this recall as Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable Compounded
- Affected units
- 189
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 (6)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 04062016@3
- 04252016@4
- 05172016@4
- 06162016@6
- 07212016@8.
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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