Flamingo Pharma UK Ltd has issued a Class 4 Medicines Defect Notification for Amitriptyline Hydrochloride tablets. The Patient Information Leaflets (PILs) accompanying these products have been found to lack critical safety information required by regulatory standards. This announcement primarily concerns clinical, quality, and regulatory teams responsible for overseeing medication compliance and patient safety.
Quick Navigation:
- What led to the notification?
- Which products were affected?
- What should teams do next?
- FAQs
- Key takeaways
- Disclaimer
- Full Announcement
What led to the notification?
On December 10, 2025, Flamingo Pharma UK Ltd informed the Medicines and Healthcare products Regulatory Agency (MHRA) about a significant issue with their Amitriptyline Hydrochloride tablets in dosages of 10 mg, 25 mg, and 50 mg. The defect stems from gaps in the patient safety information presented in the accompanying PILs. Complete and precise labeling is a critical compliance requirement under the applicable regulations to ensure safe patient use and informed clinical decisions.
According to Flamingo Pharma, the omission impacts the ability of patients and healthcare providers to access full instructions and warnings on the use of the product. While the issue does not affect the medication’s manufacturing or therapeutic quality, the regulatory expectation for safety-focused communication remains unmet.
Which products were affected?
Three variants of Amitriptyline Hydrochloride table formulations were identified:
- 10 mg tablets
- 25 mg tablets
- 50 mg tablets
The discrepancy pertains solely to the content of the PILs enclosed with the medicines and does not extend to any safety, efficacy, or manufacturing defects within the products themselves.
What should teams do next?
Clinical, quality, and regulatory professionals should promptly review and evaluate current stocks of Amitriptyline Hydrochloride tablets from Flamingo Pharma UK Ltd. It is critical to verify whether the batches in your possession are associated with incomplete patient information leaflets.
Healthcare providers may also wish to proactively inform patients using these medicines about potential gaps in labeling, particularly if specific dosage adjustments or contraindications are a concern. Regulatory teams should monitor upcoming updates from Flamingo Pharma regarding corrective measures or revised packaging containing compliant PILs.
Recommended actions:
- Audit stocks and existing batches for affected PILs.
- Communicate pertinent safety information to relevant clinical teams.
- Stay alert for updates published directly by MHRA or Flamingo Pharma.
FAQ
1. Is the medication itself unsafe?
No. This notification specifically concerns missing information in the PILs. The medication’s therapeutic safety and efficacy remain unaffected.
2. Who should act on this notification?
Clinical, quality assurance, and regulatory compliance teams in primary and secondary healthcare settings are urged to act.
3. Are other brands or medicines affected?
At this time, this issue is limited to Amitriptyline Hydrochloride tablets manufactured by Flamingo Pharma UK Ltd.
Key takeaways
Flamingo Pharma’s notification highlights the importance of maintaining accurate and comprehensive patient information in product packaging. Clinical and regulatory teams should immediately assess current inventory, ensure the distribution of accurate safety information, and monitor for corrective updates. Patient safety remains a shared responsibility; addressing this gap is a priority.
Disclaimer
This article is intended for professional audiences and serves as information only. It does not constitute legal advice for regulatory compliance decisions. Always consult the MHRA or relevant authorities for guidance.
Full Announcement
For full information about the announcement, see the link below.