HydrALAZINE Injection Recalled Due to Manufacturing Deviations and Unverified Stability
Akorn, Inc. recalled all lots of HydrALAZINE HCl Injection nationwide because the manufacturer ceased operations and could no longer conduct required stability studies.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm injectable product with no reported illnesses or injuries. The hazard is theoretical—inability to verify product stability—rather than a confirmed defect. Per the rubric, theoretical hazards without reported illness do not exceed Score 3, but the injectable drug category and manufacturing practice deviations place it at High rather than Moderate.
Plain-English summary
Akorn, Inc. recalled all lots of HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL single-dose vials due to current good manufacturing practice (CGMP) deviations. The manufacturer went out of business and could no longer continue the stability studies required to verify the product's safety and effectiveness.
The affected product was distributed nationwide in the USA and Puerto Rico. This is a prescription injectable medication administered intravenously or intramuscularly for blood pressure management.
Patients who have received this medication should consult their healthcare provider to discuss their specific situation and explore alternative treatment options. Healthcare providers should review patient records to identify individuals who may have received affected doses and discuss appropriate follow-up care.
The recalled product
- Product
- HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Injectable / Injection
- Hazard
- cgmp-deviation
- stability-unverified
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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