On September 30, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) announced a Class 2 medicines recall involving specific batches of Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation suspension. The recall, initiated by CD Pharma Ltd, involves an error on the product’s outer packaging. This notice is particularly relevant for clinical, quality, and regulatory teams who handle respiratory medications or oversee compliance with pharmaceutical labeling and safety standards.
What changed?
CD Pharma Ltd informed the MHRA of a labeling discrepancy on the outer cartons of certain Flutiform 250/10 mcg inhalers. While the total active ingredient content listed on the packaging is correct, the statement regarding the delivered dose content contains an error. This mistake could potentially lead to confusion among healthcare providers and patients, necessitating this Class 2 recall to prevent adverse outcomes.
The MHRA urges stakeholders to identify and quarantine affected batches immediately. Healthcare providers are advised to prioritize patient safety by investigating whether impacted products were dispensed to patients and to take corrective actions as necessary.
Who is affected?
This recall impacts healthcare professionals and organizations involved with prescribing, dispensing, or managing inventory for the affected medicine. Regulatory teams must ensure compliance with this notice, while clinical teams should review patient cases where these inhalers were prescribed. Pharmacists must take extra care to remove the identified batches from inventory systems and avoid further patient distribution.
The specific batch numbers and other relevant details are provided in the MHRA’s full recall statement.
Regulatory context for Class 2 recalls
Class 2 recalls signify moderate risk to patients due to labeling, packaging, or slightly substandard product quality. While not immediately life-threatening, these recalls aim to address and rectify issues that could lead to misuse or reduced treatment efficacy.
In this instance, the incongruence between the displayed “total active content” and the “delivered dose” metrics creates potential for dosage misinterpretations. MHRA guidelines state that labeling errors can compromise a medication’s intended purpose and performance, underscoring the importance of proactive recalls. CD Pharma Ltd’s notification reflects their commitment to correcting the situation promptly.
Further instructions about the recall process are available on the government’s official site. For healthcare providers and regulatory professionals, adherence to this recall signals active participation in maintaining medication safety at every level.
Frequently Asked Questions
1. What should pharmacists do with affected batches?
Pharmacists should immediately identify, segregate, and quarantine the affected batches. Follow local procedures for product recalls and notify CD Pharma Ltd or the relevant authorities as required.
2. Will patients need a replacement inhaler?
Some patients may require replacement inhalers depending on whether they have an affected batch. Healthcare providers should assess individual needs before advising replacements.
3. What is a Class 2 recall?
A Class 2 recall addresses scenarios with a medium level of risk where the issue could cause potential harm if not mitigated. In this case, the error involves labeling accuracy rather than medication composition.
Summary and actions
The Flutiform 250/10 mcg inhalers recall highlights the importance of rigorous labeling accuracy in maintaining medication safety. Clinical and pharmaceutical professionals must:
- Cross-check existing inventory for affected batch numbers.
- Communicate recall information within their teams promptly.
- Advise patients as necessary and provide replacements where needed.
Visit the MHRA website for the full recall details and further guidance.
Disclaimer
This article provides information for healthcare professionals and regulatory teams. It is not a substitute for legal advice or official guidance. All actions should comply with local regulatory frameworks.
Official announcement
For full information about the announcement, see the link below.