Class 2 Falsified Medicines Directive (FMD) alert: Action within 48 hours – various products imported by B & S Healthcare
27 Jun 2019
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.
Product and pack size |
Pack size |
Italian batch number |
B & S batch number |
Expiry date |
Date of first distribution |
Clexane injection 8000iu 0.8ml |
1 x 10 |
7CK98A |
04N0078 |
30 October 2020 |
18 April 2018 |
Clexane injection 8000iu 0.8ml |
1 x 10 |
7CH63B |
04N0016 |
30 June 2020 |
11 April 2018 |
Clexane injection 8000iu 0.8ml |
1 x 10 |
7CL23B |
03N1722 |
30 October 2020 |
22 May 2018 |
Clexane injection 8000iu 0.8ml |
1 x 10 |
7CH36C |
03N1721 |
30 June 2020 |
11 April 2018 |
Clexane injection 8000iu 0.8ml |
1 x 10 |
7CH77B |
03N1721 |
30 June 2020 |
11 April 2018 |
Clexane injection 8000iu 0.8ml |
1 x 10 |
7CL82B |
03N1720 |
30 November 2020 |
11 May 2018 |
Clexane injection 8000iu 0.8ml |
1 x 10 |
7CL37D |
03N1722 |
30 October 2020 |
22 May 2018 |
Clexane injection 8000iu 0.8ml |
1 x 10 |
8CA66C |
03N1716 |
30 December 2020 |
10 May 2018 |
Dovobet gel |
1 x 30g |
A80960 |
11N0735 |
30 July 2020 |
6 December 2018 |
Dovobet gel |
1 x 30g |
A79729 |
11N0734 |
30 June 2020 |
5 December 2018 |
Dovobet gel |
1 x 30g |
A85747 |
01P0222 |
30 October 2020 |
9 January 2019 |
Dovobet gel |
1 x 30g |
A78018 |
01P0850 |
30 May 2020 |
16 January 2019 |
Dovobet gel |
1 x 30g |
A80960 |
01P0221 |
30 July 2020 |
9 January 2019 |
Dovobet gel |
1 x 30g |
A87671 |
02P1199 |
30 October 2020 |
2 April 2019 |
Dovobet gel |
1 x 30g |
A85936 |
02P1206 |
30 October 2020 |
19 March 2019 |
Dovobet gel |
1 x 30g |
A85747 |
02P1207 |
30 October 2020 |
29 April 2019 |
Dovobet gel |
1 x 30g |
A88301 |
02P1205 |
30 November 2021 |
15 May 2019 |
Dovobet gel |
1 x 30g |
A80960 |
02P1204 |
30 July 2020 |
30 April 2019 |
Dovobet gel |
1 x 30g |
A89721 |
04P0609 |
30 November 2021 |
14 May 2019 |
Dovobet gel |
1 x 30g |
A90279 |
03P1677 |
30 December 2021 |
12 April 2019 |
Dovobet gel |
1 x 30g |
A85936 |
03P1679 |
30 October 2020 |
14 May 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R829935 |
06N0036 |
30 June 2019 |
7 June 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R834141 |
05N0506 |
30 September 2019 |
21 May 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R839098 |
05N0750 |
30 October 19 |
23 May 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R838744 |
05N0659 |
30 October 2019 |
22 May 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R844186 |
05N0657 |
30 December 2019 |
21 May 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R851918 |
11N0754 |
30 March 2020 |
27 November 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R856773 |
11N0753 |
30 July 2020 |
21 November 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R853231 |
11N0755 |
30 March 2020 |
21 November 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R849465 |
11N0752 |
28 February 2020 |
22 November 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R853231 |
01P0344 |
30 March 2020 |
9 January 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R851918 |
01P0345 |
30 March 2020 |
9 January 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R856773 |
12N0071 |
30 July 2020 |
7 December 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R858970 |
01P0343 |
30 August 2020 |
9 January 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R856773 |
12N0808 |
30 July 2020 |
31 December 2018 |
Incruse inhaler 55mcg |
1 x 30 doses |
R852223 |
01P0344 |
30 March 2020 |
9 January 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R858970 |
02P1201 |
30 August 2020 |
11 April 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R856773 |
02P1200 |
30 July 2020 |
18 April 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R851918 |
02P1209 |
30 March 2020 |
18 April 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R861997 |
03P0530 |
30 September 2020 |
28 March 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R860226 |
03P0991 |
30 August 2020 |
27 March 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R861997 |
03P0955 |
30 September 2020 |
3 April 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R860226 |
03P1676 |
30 August 2020 |
5 April 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R861997 |
03P1675 |
30 September 2020 |
11 April 2019 |
Incruse inhaler 55mcg |
1 x 30 doses |
R861997 |
04P1150 |
30 September 2020 |
29 April 2019 |
Neupro patch 4mg/24hrs |
1 x 28 |
56688403 |
05N0469 |
28 February 2020 |
1 June 2018 |
Neupro patch 4mg/24hrs |
1 x 28 |
56679402 |
06N0592 |
30 January 2020 |
14 June 2018 |
Neupro patch 4mg/24hrs |
1 x 28 |
56712404 |
10N1295 |
30 June 2020 |
31 October 2018 |
Neupro patch 4mg/24hrs |
1 x 28 |
56722401 |
10N1292 |
30 July 2020 |
2 November 2018 |
Neupro patch 4mg/24hrs |
1 x 28 |
56728403 |
10N1296 |
30 August 2020 |
26 October 2018 |
Neupro patch 4mg/24hrs |
1 x 28 |
56722401 |
11N0650 |
30 July 2020 |
23 November 2018 |
Neupro patch 4mg/24hrs |
1 x 28 |
56712403 |
11N0649 |
30 June 2020 |
22 November 2018 |
Neupro patch 4mg/24hrs |
1 x 28 |
56742401 |
11N0651 |
30 November 2020 |
6 December 2018 |
Neupro patch 4mg/24hrs |
1 x 28 |
56728403 |
11N0647 |
30 August 2020 |
26 November 2018 |
Neupro patch 4mg/24hrs |
1 x 28 |
56712404 |
11N0648 |
30 June 2020 |
26 November 2018 |
Neupro patch 4mg/24hrs |
1 x 28 |
56699404 |
04P1286 |
30 April 2020 |
14 May 2019 |
Neupro patch 4mg/24hrs |
1 x 28 |
56728403 |
01P0366 |
30 August 2020 |
14 January 2019 |
Neupro patch 4mg/24hrs |
1 x 28 |
56742401 |
01P0314 |
30 November 2020 |
9 January 2019 |
Neupro patch 4mg/24hrs |
1 x 28 |
56757104 |
04P1278 |
30 January 2021 |
3 May 2019 |
Neupro patch 4mg/24hrs |
1 x 28 |
56763103 |
04P1279 |
30 January 2021 |
3 May 2019 |
Provisacor tablets 10mg (Sold as Crestor) |
1 x 28 |
U733A |
04N1584 |
30 April 2020 |
8 May 2018 |
Provisacor tablets 10mg (Sold as Crestor) |
1 x 28 |
U571A |
05N0155 |
28 February 2020 |
29 May 2018 |
SEEBRI BREEZHALER 44mg |
1 x 30 doses |
BFD79 |
04PO113 |
30 July 2020 |
18 April 2019 |
Spiriva Inhalation powder capsules 18mcg |
1 x 30 |
802223 |
01P0226 |
28 February 2020 |
9 January 2019 |
Spiriva Inhalation powder capsules 18mcg |
1 x 30 |
804102 |
01P0227 |
30 May 2020 |
9 January 2019 |
Vimpat tablets 100mg |
1 X 56 |
254265 |
01P0324 |
30 April 2023 |
11 January 2019 |
Vimpat tablets 100mg |
1 X 56 |
255279 |
02P1067 |
30 April 2023 |
19 March 2019 |
Vimpat tablets 100mg |
1 X 56 |
258582 |
02P0892 |
30 June 2023 |
25 March 2019 |
Vimpat tablets 100mg |
1 X 56 |
254265 |
02P0893 |
30 April 2023 |
25 March 2019 |
Further information can be found on the MHRA section on the GOV.UK website.
Produced by the NPA Pharmacy team June 2019