Promise Pharmacy, LLC recalls Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists…
- Recall date
- December 17, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0476-2019
- FDA classification
- Class II
- Brand / firm
- Promise Pharmacy, LLC
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
Lack of sterility assurance.
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 injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
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