Norgine: MOVICOL Plain Recall EL(26)A/41 Issued Over Incorrect Ingredients

• Norgine Limited has issued a Class 3 Medicines Recall for specific batches of MOVICOL Plain 13.7g powder for oral solution, identified as EL(26)A/41.
• The recall is a precautionary measure due to some units containing incorrect amounts of active ingredients.
• Pharmacies, distributors, and GPs must immediately stop supplying, quarantine, and return affected stock.
• Patients are not required to take any action and may continue using the medicine, but should report any adverse reactions via the MHRA Yellow Card scheme.
• The recall is being managed at the retail and wholesale levels, with no direct patient-level action required.

Compliance officers within these organizations must ensure that these recall procedures are meticulously followed to prevent any further distribution of the affected MOVICOL Plain.

Norgine Limited has initiated a Class 3 Medicines Recall for specific batches of its MOVICOL Plain 13.7g powder for oral solution, identified by the reference EL(26)A/41. This Norgine Limited product recall is a precautionary measure, prompted by the discovery that some units within the affected batches contain incorrect amounts of active ingredients. The active ingredients in question are macrogol 3350, sodium chloride, sodium hydrogen carbonate, and potassium chloride.

The recall notice specifies that the affected product has a SNOMED code of 11588511000001108 and a GTIN of 05012748615328. This Norgine MOVICOL Plain recall EL(26)A/41 underscores the pharmaceutical industry's commitment to patient safety, even when issues are identified as a matter of caution rather than immediate danger. The presence of incorrect active ingredients, even in varying amounts, necessitates stringent action to maintain product integrity and public trust.

In response to the Norgine MOVICOL Plain 13.7g powder recall, all entities involved in the supply chain, including pharmaceutical distributors, pharmacies, and dispensing general practitioners, are mandated to take immediate action. The MHRA drug recall notice explicitly instructs them to cease supplying the identified batches without delay. Furthermore, all remaining stock of the affected product must be quarantined.

Following quarantine, the stock is to be returned to the respective supplier, adhering strictly to the supplier's established return process. This rigorous procedure is crucial for mitigating compliance risks and potential liability for healthcare providers and distributors. Compliance officers within these organizations must ensure that these recall procedures are meticulously followed to prevent any further distribution of the affected MOVICOL Plain. This Class 3 Medicines Recall Norgine action highlights the critical role of robust inventory management and recall protocols in the pharmaceutical sector.

Crucially, patients currently in possession of the affected MOVICOL Plain 13.7g powder for oral solution are not required to take any immediate action regarding their medication. The Norgine Limited product recall is being conducted solely at the retail and wholesale levels, meaning the risk to individual patients is considered low. Patients may continue to take this medicine as prescribed, as the recall is undertaken out of an abundance of caution rather than an immediate safety threat.

However, individuals who experience any adverse reactions or have questions concerning their medication should promptly seek medical attention from a healthcare professional. Any suspected adverse reactions related to the MOVICOL Plain 13.7g powder recall should also be reported through the MHRA Yellow Card scheme, a vital system for monitoring drug safety. This ensures that any potential issues are documented and investigated thoroughly.

Effective communication is a cornerstone of any successful product recall. Recipients of this Class 3 Medicines Recall Norgine notification are urged to bring it to the attention of all relevant contacts within their organizations. Specifically, NHS regional teams have been tasked with forwarding this important information to community pharmacists and dispensing general practitioners, ensuring widespread awareness across the healthcare network.

For medical information inquiries or general product information regarding the MOVICOL Plain 13.7g powder recall, Norgine Limited has provided a dedicated email address, MedInfo@norgine.com, and a telephone number, +44 (0) 1895 826606. For stock control inquiries related to the incorrect active ingredients recall, parties can contact UKIsupport@norgine.com or call +44 (0) 1895 826600. These channels are vital for ensuring that all stakeholders can obtain necessary clarification and support during the recall process.

Lawyers advising pharmaceutical distributors, pharmacies, or healthcare providers must immediately inform clients of the requirement to cease supply, quarantine, and return affected MOVICOL Plain batches to mitigate compliance risks and potential liability. Compliance officers in these entities need to ensure the recall procedures are strictly followed.

Source: Original reporting via UK government notice.