Akorn recalls HydrALAZINE HCl injection vials due to inability to conduct stability studies after the company went out of business. All units are affected. No remedy specified in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all HydrALAZINE HCl injection vials (20 mg/mL, 1 mL single dose) because the manufacturer went out of business and can no longer perform stability testing. This means the product's safety and effectiveness cannot be guaranteed.
The manufacturer went out of business and could no longer conduct stability studies to ensure the product remains safe and effective over time. Without this testing, there is uncertainty about whether the medication will maintain its intended properties.
Prescription drug users who have the HydrALAZINE HCl injection vials. Patients at risk are those who may have received the medication without proper stability testing.
Check for HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials. All units are affected, including all NDCs and lots.
Identify if you have HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials.
The manufacturer went out of business and could no longer continue stability studies, so the product's safety and effectiveness cannot be guaranteed.
The official notice does not specify a remedy, so there is no instruction to stop using or discard the product.
All units of HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials are affected, including all NDCs and lots.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0809-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0809-2023 from Akorn. 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.
