FMD Alert: Class 2 (MDR 123-05/19)

Medicines have been taken out of the regulated medicines’ supply chain during distribution. The products have been parallel imported into the UK by B & S Healthcare from Italy and have been re-labelled in B & S Healthcare livery.

MDR Number

MDR 123-05/19

Company Name

B & S Healthcare

Product description

Please see table below for list of products and batch numbers. The list of products is also included in the document at the bottom of the page.

Brief description of the issue

FMD1 Alert: Class 2.

It has recently come to our attention that medicines have been taken out of the regulated medicines’ supply chain during distribution and later re-introduced. This means that the correct transport and storage conditions cannot be guaranteed during this period and, while unlikely, could impact their effectiveness.

The products have been parallel imported into the UK by B & S Healthcare from Italy and have been re-labelled in B & S Healthcare livery. The same batches of products may have been parallel imported legitimately into the UK by other importers. Only those packs in B & S Healthcare livery are within the scope of this Alert.

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.

Advice for healthcare professionals

  • Please check your stocks of all the listed products for the relevant batches in B & S Healthcare livery. If any relevant packs are identified, please quarantine and return it to your supplier using your supplier’s approved process.
  • The MHRA has undertaken a medical assessment to determine whether there is any risk to patients. As a precautionary measure, three medicines are being recalled to a patient level because in the very unlikely event that these medicines are not fully effective there is a potential risk to patient safety. For these three particular medicines, 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.
  • The three products that are being recalled to patient level are Clexane 8000iu Injection 0.8ml; Neupro 4mg/24 hr patches; and Vimpat 100mg tablets. We will use media, social media and will contact patient groups and charities, to help draw the attention of patients to the affected batches of these products.
  • As a precaution, all other affected medicines are being recalled at pharmacy level. Again, you should advise patients to continue taking their medicines. If they have any of these affected products, they do not need to arrange a new prescription, but if they have any questions, they should speak to their GP or healthcare professional. The products being recalled at pharmacy level are: Dovobet Gel, Incruse Inhaler, Provisacor (Crestor) 10mg Tablets, Seebri Breezhaler, Spiriva Inhalation Powder.

Contact details for further information

For general enquiries please contact B & S Healthcare customer services:

Email: customerservice@bnshealthcare.com

For medical information enquiries please contact the B & S Healthcare medical information team:

Email: medinfo@bnshealthcare.com

Table of products / batches

Product and Pack Size Italian Batch Number B & S Batch Number Expiry Date Date of First Distribution
Clexane 8000iu 0.8ml 1 x 10 7CK98A 04N0078 30-OCT-20 18-APR-18
Clexane 8000iu 0.8ml 1 x10 7CH63B 04N0016 30-JUN-20 11-APR-18
Clexane 8000iu 0.8ml 1 x 10 7CL23B 03N1722 30-OCT-20 22-MAY-18
Clexane 8000iu 0.8ml 1 x10 7CH36C 03N1721 30-JUN-20 11-APR-18
Clexane 8000iu 0.8ml 1 x 10 7CH77B 03N1721 30-JUN-20 11-APR-18
Clexane 8000iu 0.8ml 1 x 10 7CL82B 03N1720 30-NOV-20 11-MAY-18
Clexane 8000iu 0.8ml 1 x 10 7CL37D 03N1722 30-OCT-20 22-MAY-18
Clexane 8000iu 0.8ml 1 x 10 8CA66C 03N1716 30-DEC-20 10-MAY-18
Dovobet Gel 1 x 30g A80960 11N0735 30-JUL-20 06-DEC-18
Dovobet Gel 1 x 30g A79729 11N0734 30-JUN-20 05-DEC-18
Dovobet Gel 1 x 30g A85747 01P0222 30-OCT-20 09-JAN-19
Dovobet Gel 1 x 30g A78018 01P0850 30-MAY-20 16-JAN-19
Dovobet Gel 1 x 30g A80960 01P0221 30-JUL-20 09-JAN-19
Dovobet Gel 1 x 30g A87671 02P1199 30-OCT-20 02-APR-19
Dovobet Gel 1 x 30g A85936 02P1206 30-OCT-20 19-MAR-19
Dovobet Gel 1 x 30g A85747 02P1207 30-OCT-20 29-APR-19
Dovobet Gel 1 x 30g A88301 02P1205 30-NOV-21 15-MAY-19
Dovobet Gel 1 x 30g A80960 02P1204 30-JUL-20 30-APR-19
Dovobet Gel 1 x 30g A89721 04P0609 30-NOV-21 14-MAY-19
Dovobet Gel 1 x 30g A90279 03P1677 30-DEC-21 12-APR-19
Dovobet Gel 1 x 30g A85936 03P1679 30-OCT-20 14-MAY-19
Incruse Inhaler 55Mcg 1 x 30 Doses R829935 06N0036 30-JUN-19 07-JUN-18
Incruse Inhaler 55Mcg 1 x 30 Doses R834141 05N0506 30-SEP-19 21-MAY-18
Incruse Inhaler 55Mcg 1 x 30 Doses R839098 05N0750 30-OCT-19 23-MAY-18
Incruse Inhaler 55Mcg 1 x 30 Doses R838744 05N0659 30-OCT-19 22-MAY-18
Incruse Inhaler 55Mcg 1 x 30 Doses R844186 05N0657 30-DEC-19 21-MAY-18
Incruse Inhaler 55Mcg 1 x 30 Doses R851918 11N0754 30-MAR-20 27-NOV-18
Incruse Inhaler 55Mcg 1 x 30 Doses R856773 11N0753 30-JUL-20 21-NOV-18
Incruse Inhaler 55Mcg 1 x 30 Doses R853231 11N0755 30-MAR-20 21-NOV-18
Incruse Inhaler 55Mcg 1 x 30 Doses R849465 11N0752 28-FEB-20 22-NOV-18
Incruse Inhaler 55Mcg 1 x 30 Doses R853231 01P0344 30-MAR-20 09-JAN-19
Incruse Inhaler 55Mcg 1 x 30 Doses R851918 01P0345 30-MAR-20 09-JAN-19
Incruse Inhaler 55Mcg 1 x 30 Doses R856773 12N0071 30-JUL-20 07-DEC-18
Incruse Inhaler 55Mcg 1 x 30 Doses R858970 01P0343 30-AUG-20 09-JAN-19
Incruse Inhaler 55Mcg 1 x 30 Doses R856773 12N0808 30-JUL-20 31-DEC-18
Incruse Inhaler 55MCg 1 x 30 Doses R852223 01P0344 30-MAR-20 09-JAN-19
Incruse Inhaler 55Mcg 1 x 30 Doses R858970 02P1201 30-AUG-20 11-APR-19
Incruse Inhaler 55Mcg 1 x 30 Doses R856773 02P1200 30-JUL-20 18-APR-19
Incruse Inhaler 55Mcg 1 x 30 Doses R851918 02P1209 30-MAR-20 18-APR-19
Incruse Inhaler 55Mcg 1 x 30 Doses R861997 03P0530 30-SEP-20 28-MAR-19
Incruse Inhaler 55Mcg 1 x 30 Doses R860226 03P0991 30-AUG-20 27-MAR-19
Incruse Inhaler 55Mcg 1 x 30 Doses R861997 03P0955 30-SEP-20 03-APR-19
Incruse Inhaler 55Mcg 1 x 30 Doses R860226 03P1676 30-AUG-20 05-APR-19
Incruse Inhaler 55Mcg 1 x 30 Doses R861997 03P1675 30-SEP-20 11-APR-19
Incruse Inhaler 55Mcg 1 x 30 Doses R861997 04P1150 30-SEP-20 29-APR-19
Neupro 4mg/24hrs 1 x 28 Patches 56688403 05N0469 28-FEB-20 01-JUN-18
Neupro 4mg/24hrs 1 x 28 Patches 56679402 06N0592 30-JAN-20 14-JUN-18
Neupro 4mg/24hrs 1 x 28 Patches 56712404 10N1295 30-JUN-20 31-OCT-18
Neupro 4mg/24hrs 1 x 28 Patches 56722401 10N1292 30-JUL-20 02-NOV-18
Neupro 4mg/24hrs 1 x 28 Patches 56728403 10N1296 30-AUG-20 26-OCT-18
Neupro 4mg/24hrs 1 x 28 Patches 56722401 11N0650 30-JUL-20 23-NOV-18
Neupro 4mg/24hrs 1 x 28 Patches 56712403 11N0649 30-JUN-20 22-NOV-18
Neupro 4mg/24hrs 1 x 28 Patches 56742401 11N0651 30-NOV-20 06-DEC-18
Neupro 4mg/24hrs 1 x 28 Patches 56728403 11N0647 30-AUG-20 26-NOV-18
Neupro 4mg/24hrs 1 x 28 Patches 56712404 11N0648 30-JUN-20 26-NOV-18
Neupro 4mg/24hrs 1 x 28 Patches 56699404 04P1286 30-APR-20 14-MAY-19
Neupro 4mg/24hrs 1 x 28 Patches 56728403 01P0366 30-AUG-20 14-JAN-19
Neupro 4mg/24hrs 1 x 28 Patches 56742401 01P0314 30-NOV-20 09-JAN-19
Neupro 4mg/24hrs 1 x 28 Patches 56757104 04P1278 30-JAN-21 03-MAY-19
Neupro 4mg/24hrs 1 x 28 Patches 56763103 04P1279 30-JAN-21 03-MAY-19
Provisacor (Sold as Crestor) 10Mg Tabs 1 x 28 U733A 04N1584 30-APR-20 08-MAY-18
Provisacor (Sold as Crestor) 10Mg Tabs 1 x 28 U571A 05N0155 28-FEB-20 29-MAY-18
SEEBRI BREEZHALER 44mg 1 x 30 Doses BFD79 04PO113 30-JUL-20 18-APR-19
Spiriva Inhalation Powder 18mcg Cap 1 x 30 802223 01P0226 28-FEB-20 09-JAN-19
Spiriva Inhalation Powder 18mcg Cap 1 x 30 804102 01P0227 30-MAY-20 09-JAN-19
VIMPAT 100MG TABS 1 X 56 254265 01P0324 30-APR-23 11-JAN-19
VIMPAT 100MG TABS 1 X 56 255279 02P1067 30-APR-23 19-MAR-19
VIMPAT 100MG TABS 1 X 56 258582 02P0892 30-JUN-23 25-MAR-19
VIMPAT 100MG TABS 1 X 56 254265 02P0893 30-APR-23 25-MAR-19

Recipients of this Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.

Download the document

FMD Alert: Class 2 (MDR 123-05/19)

  1. Falsified Medicines Directive Alert

    Falsified Medicines Directive (FMD) 2011/62/EU introduced new requirements to enhance the security of the European supply chain. Where the MHRA has identified risks to the security of the supply chain, FMD Alerts will be issued.

    There is further information about FMD and safety features on our website

Published 27 June 2019