A batch of a multiple sclerosis (MS) medication has been recalled due to a manufacturing issue that affects the dissolution of the capsules. The medication, called Copaxone, is a glatiramer acetate injection used to treat relapsing forms of MS. The recall was initiated by the manufacturer, Teva Pharmaceuticals, after it was discovered that some capsules may not be dissolving at the expected rate.
The issue was identified during routine testing, which revealed that some capsules were not meeting the required dissolution specifications. As a result, Teva Pharmaceuticals has recalled the affected batch, which was distributed in the UK and other countries. The company has stated that the recall is a precautionary measure to ensure the quality and efficacy of the medication.
The slow dissolution of the capsules may affect the release of the active ingredient, glatiramer acetate, which could potentially impact the medication’s effectiveness in managing MS symptoms. However, Teva Pharmaceuticals has emphasized that there is no evidence to suggest that the affected batch poses a safety risk to patients.
Patients who are currently taking Copaxone are advised to check their medication packaging to see if it is part of the recalled batch. The affected batch numbers and expiry dates can be found on the Medicines and Healthcare products Regulatory Agency (MHRA) website. If a patient has a recalled batch, they should contact their pharmacist or healthcare provider for advice on what to do next.
Teva Pharmaceuticals has assured patients that alternative supplies of Copaxone are available, and that they are working to rectify the issue as quickly as possible. The company has also stated that it is cooperating fully with regulatory authorities to resolve the issue.
The recall highlights the importance of quality control measures in the pharmaceutical industry. Regular testing and inspection of medications are crucial to ensuring that they meet the required standards of quality, safety, and efficacy. The MHRA has stated that it is monitoring the situation closely and will take further action if necessary to protect public health.
In the meantime, patients with MS are advised to continue taking their medication as prescribed, unless advised otherwise by their healthcare provider. If patients have any concerns or questions about the recall, they should contact their pharmacist or healthcare provider for guidance and support.