TriMix Injection 100mcg/30mg/3mg/mL INJECTABLE recalled over sterility concerns
- Recall date
- December 30, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Northern VA Compounders PLLC recalls TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials,…
- Recall number
- D-0116-2023
- FDA classification
- Class II
- Brand / firm
- Northern VA Compounders PLLC
- Sold / distributed
- Nationwide in the USA
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
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
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