Advanz Pharma: Mynzepli Recall UK for Defective Syringes

• Advanz Pharma Limited has initiated a Class 2 Medicines Recall for specific batches of Mynzepli 40 mg/mL solution for injection in pre-filled syringes in the UK.
• The recall is a precautionary measure due to a small variation in the finger grip size, which could affect administration and patient safety.
• Pharmacies and wholesalers must immediately stop supplying, quarantine, and return all affected stock to their suppliers.
• This recall is at the pharmacy and wholesaler level, with no direct action required from patients.
• Unaffected batches of Mynzepli are currently available, and the product is administered solely by qualified healthcare professionals.

Compliance officers and legal counsel within these organizations must ensure that all remaining stock of the recalled product is promptly quarantined and returned to the respective suppliers, strictly following the supplier's established return procedures.

Advanz Pharma Limited has issued a precautionary Class 2 Medicines Recall in the UK for specific batches of its Mynzepli 40 mg/mL solution for injection, supplied in pre-filled syringes. This action, designated EL(26)A/44, stems from the identification of a minor manufacturing variation concerning the finger grip component of the syringe. The affected product contains aflibercept as its active ingredient, identified by SNOMED code 45567511000001107 and GTIN 05021691005605.

The recall was prompted by concerns that a slight deviation in the finger grip's size could potentially compromise the proper administration of the medication. The finger grip is crucial for providing a stable platform, enabling users to securely hold the pre-filled syringe and apply the necessary pressure to the plunger rod during the injection process. Any impairment to this function could introduce a risk to patient safety during administration. This Advanz Pharma Mynzepli recall UK specifically targets batches where this variation has been observed.

The Medicines and Healthcare products Regulatory Agency (MHRA) has classified this as a Class 2 medicines recall, indicating that the issue could cause harm but is not immediately life-threatening. Consequently, all pharmacies and wholesalers in the UK are mandated to immediately cease supplying any of the identified affected batches of Mynzepli 40 mg/mL syringe recall. Compliance officers and legal counsel within these organizations must ensure that all remaining stock of the recalled product is promptly quarantined and returned to the respective suppliers, strictly following the supplier's established return procedures.

It is important to note that this is a recall at the pharmacy and wholesaler level, meaning patients are not required to take any direct action. The Mynzepli 40 mg/mL solution for injection is exclusively administered by qualified healthcare professionals who possess experience in performing intravitreal injections. Advanz Pharma has confirmed that unaffected batches of the product remain available for distribution, ensuring continuity of treatment where necessary. Any suspected adverse reactions to the medication should be reported through the MHRA Yellow Card scheme, and patients with concerns should seek medical attention.

The primary objective of this aflibercept recall UK is to proactively address a potential administration issue before it leads to patient harm. For legal and compliance teams overseeing pharmaceutical operations, verifying adherence to the MHRA's recall directives is paramount. This includes not only the physical cessation of supply and return of stock but also ensuring internal protocols are updated to reflect such recall events, thereby mitigating regulatory non-compliance risks and potential product liability exposure.

For any inquiries related to the recalled Mynzepli product, Advanz Pharma Limited has provided direct contact channels: medicalinformation@advanzpharma.com or by telephone at +44 (0) 208 588 9131. Recipients of the recall notice are also responsible for disseminating this critical information to relevant contacts, with NHS regional teams specifically tasked with forwarding the notice to community pharmacists and dispensing general practitioners to ensure widespread awareness of the defective pre-filled syringe issue.

Compliance officers and legal counsel for pharmacies, wholesalers, and healthcare providers must ensure immediate cessation of supply, quarantine of affected Mynzepli batches, and adherence to the specified return process to mitigate regulatory non-compliance risks and potential product liability exposure. They should verify internal procedures align with MHRA recall directives.

Source: Original reporting via UK Government MHRA.