Meta description: Maxearn Limited recalls Inhixa 12,000IU injection due to carton labeling error. Learn about the issue, impact, and actions required by healthcare professionals.
Maxearn Limited has announced a recall of two batches of Inhixa 12,000IU (120mg)/0.8mL solution for injection because of a typographical error on the packaging. Healthcare providers and regulatory teams handling this product should pay close attention to the details outlined below.
- What changed?
- Who is affected?
- What are the recommended actions?
- FAQ
- Recap
- Disclaimer
- Announcement Link
What changed?
Maxearn Limited reported that two batches of Inhixa 12,000IU (120mg)/0.8mL, a solution used for injection, were released to the market with incorrect carton labeling on one side. While the typographical error does not compromise the product formulation or its functionality, proper labeling is critical to ensure safe administration and compliance with regulatory standards.
Who is affected?
This recall is directed at clinical, quality assurance, and regulatory professionals handling Inhixa. Pharmacies, hospitals, and healthcare providers administering this product must ensure that affected batches are identified and managed according to recall instructions. Importantly, end-users and patients may remain unaware of the packaging error, thus requiring communication from their providers.
What are the recommended actions?
For clinical teams:
- Identify whether your inventory includes the impacted batches of Inhixa 12,000IU.
- Follow the recall instructions provided by Maxearn Limited or your distributor to return or replace the involved products.
- Communicate clearly with patients or caregivers if the impacted product has already been administered to ensure safety monitoring.
For regulatory teams:
- Review the incident against current regulatory labeling requirements and consider whether additional action is needed.
- Engage with Maxearn Limited to report compliance with recall procedures and verify remediation timelines.
For quality teams:
- Audit existing stock to ensure all affected boxes are segregated and removed promptly.
- Document mitigation actions in alignment with internal quality management systems.
FAQ
- What batches of Inhixa are impacted?
Two specific batches imported by Maxearn Limited. Each lot number is detailed in the official recall announcement. - Is the product safe to use?
While the formulation and quality of the product remain unaffected, the labeling error necessitates caution during administration. - Where can I find more information?
See the link at the end of this post for the official announcement.
Recap
Maxearn Limited has recalled two batches of Inhixa 12,000IU due to a typographical error on their cartons. Clinical, quality, and regulatory professionals should act urgently to isolate and address affected stock. Although the product quality remains intact, proper labeling safeguards clinical decisions and compliance.
Disclaimer
The information provided here is for healthcare and regulatory professionals. This content is not legal advice. Verify all actions with your internal protocols and governing standards.
Announcement Link
For full information about the announcement, see the link below.
https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-inhixa-12000iu-120mg-slash-0-dot-8ml-solution-for-injection-maxearn-limited-el-25-a-slash-27