FMD Alert: Class 2 (EL (19)A/15)
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
FMD[footnote 1] 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.
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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. ↩