Jubilant Pharmaceuticals NV has reported a packaging error involving certain batches of Olmesartan medoxomil 10mg film-coated tablets. According to the announcement made by the Medicines and Healthcare products Regulatory Agency (MHRA) on September 30, 2025, the cartons for these batches contain an outdated Patient Information Leaflet (PIL). Clinical, quality, and regulatory teams should be informed and take note immediately for compliance and patient safety.
What changed?
The affected batches of Olmesartan medoxomil 10mg tablets contain a Patient Information Leaflet that has not been updated to reflect recent changes. Jubilant Pharmaceuticals NV communicated this issue to the MHRA, prompting the regulatory notification. This error directly impacts the alignment of patient-facing information with current pharmacological guidelines and drug safety updates.
Who is affected?
This notification concerns clinical, quality, and regulatory teams responsible for handling medicines distribution, compliance, and patient safety. Pharmacists dispensing these batches should exercise caution. Healthcare professionals using or prescribing Olmesartan medoxomil should ensure patients receive the correct and updated information. Additionally, patients prescribed these medications may inadvertently receive outdated guidance due to this defect.
What are the potential risks?
Outdated Patient Information Leaflets can pose several risks, including:
- Miscommunication about the proper dosage instructions.
- Incomplete warnings about potential adverse effects.
- Confusion regarding contraindications or drug interactions.
While the active drug itself remains unaffected, the lack of correct supporting documentation could compromise patient understanding and safety. Ensuring accurate medication labeling and accessibility to up-to-date guidelines is an essential regulatory requirement under MDR standards.
Manufacturer Statement
Jubilant Pharmaceuticals NV has acknowledged the defect and committed to addressing the issue promptly. Healthcare professionals are advised to monitor for updated instructions concerning the affected batches.
FAQ
- What batches are affected?
The MHRA’s notification specifies only those batches indicated in their formal release. Detailed batch information can be obtained from their announcement link below. - Can patients still use these tablets?
Yes, the medication itself is unaffected. However, healthcare professionals should ensure patients receive the updated PIL for accurate safety guidelines. - What actions should healthcare providers take?
Clinicians and pharmacists should check their stock for affected batches and distribute the appropriate updated information to patients.
What should you do next?
If you are part of a clinical or regulatory team, verify your inventory for the affected batches and ensure correct documentation is provided to patients. Facilities should proactively contact Jubilant Pharmaceuticals NV or MHRA for additional clarification or replacement materials.
Disclaimer
This article is intended for informational purposes only and should not be considered as legal or regulatory advice. Always refer directly to the MHRA notifications and official statements for authoritative guidance.
Announcement Link
For full information about the announcement, see the link below.