Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Denver Solutions, LLC DBA Leiters Health to request your refund or repair — edit it as you like.
Subject: Recall D-0280-2024 — Denver Solutions, LLC DBA Leiters Health Denver Solutions, LLC DBA Leiters Health recalls PHENYLeph Hello, I own a Denver Solutions, LLC DBA Leiters Health recalls PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 that is covered by recall D-0280-2024 from Denver Solutions, LLC DBA Leiters Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
