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FMD Class 2 alert issued for B&S Healthcare parallel imports

Range of products recalled as precaution

June 28th 2019

Tagged: MHRA alert FMD

By Charles Gladwin

A class 2 product recall is in place for a number of products parallel imported from Italy by B&S Healthcare and re-labelled in B&S livery.
Three items need to be recalled at a patient level:

• Clexane 8000iu Injection 0.8ml;
• Neupro 4mg/24 hr patches;
• Vimpat 100mg tablets.

In addition, the following are being recalled from dispensaries/pharmacies:

• Dovobet Gel;
• Incruse Inhaler;
• Provisacor (Crestor) 10mg Tablets;
• Seebri Breezhaler;
• Spiriva Inhalation Powder.

The full list of products included in the recall, with their Italian batch numbers, B&S batch numbers, expiry and first distribution dates, is given on the MHRA alert.

The recall is due to medicines having been taken out of the regulated medicines’ supply chain (under the Falsified Medicines Directive – FMD) during distribution. As the integrity of the FMD chain was broken, the correct transport and storage conditions cannot be guaranteed during this period “and, while unlikely, could impact their effectiveness.”

The MHRA added: “The products are believed to be legitimate. There is no evidence that they have been tampered with and these medicines are stable at room temperature.”

The products in the patient-level recall are those where “in the very unlikely event that these medicines are not fully effective there is a potential risk to patient safety.

“Whilst the likelihood of their effectiveness being compromised is low (because they are stable legitimate medicines), the consequences of a lack of effectiveness could be serious which is why we are treating them differently.

“If patients have any of these affected products, you should advise that they should continue taking their medicines and contact their GP practice to arrange a new prescription. Once they have a new prescription, patients should return the affected batches to their pharmacist.”

Contact emails for B&S Healthcare are: [email protected] or [email protected]