Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable recalled over sterility concerns
- Recall date
- September 21, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Wells Pharmacy Network LLC recalls Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Recall number
- D-0364-2017
- FDA classification
- Class II
- Brand / firm
- Wells Pharmacy Network LLC
- Sold / distributed
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
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