Bi-Mix a) Injectable recalled over sterility concerns
- Recall date
- September 10, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Pharm D Solutions, LLC recalls Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm…
- Recall number
- D-0144-2019
- FDA classification
- Class II
- Brand / firm
- Pharm D Solutions, 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
Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houston, Texas
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