Class 2 Falsified Medicines Directive (FMD) alert: Action within 48 hours – various products imported by B & S Healthcare

A Class 2 FMD alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain batches of products imported by B & S Healthcare

DRUG ALERT

Class 2 Falsified Medicines Directive (FMD) alert – Action within 48 hours

Ref: EL(19)A/15

27 June 2019

Various products imported by B & S Healthcare

A Class 2 FMD alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for the batches of products listed in the table below as they have been removed from the regulated medicines supply chain during distribution and have then been re-introduced at a later date. As the products were removed from the regulated supply chain, there is no guarantee that the medicines were stored or transported in the correct conditions.

Although the affected medicines are likely to be fully effective, three of the medicines are being recalled to patient level due to the potential risk to patient safety – they are Clexane injection 8000iu in 0.8ml, Neupro patches 4mg/24hr hours and Vimpat tablets 100mg.

A pharmacy level recall has been actioned for all the other affected medicines as outlined below. Pharmacies are advised to check to see if they have any of the affected products and if any are identified then they should be quarantined and returned to the original supplier.

For general enquiries B&S Healthcare customer services can be contacted via email customerservice@bnshealthcare.com.

For medical information enquiries B&S Healthcare medical information can be contacted via email medinfo@bnshealthcare.com.

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy team June 2019