Class 2 Medicines Recall: Teva UK Limited and Mylan – recall of some Valsartan containing products

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Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.

Class 2 Medicines Recall: Teva UK Limited and Mylan – recall of some Valsartan containing products – GOV.UK

Company name

Teva UK Limited

Valsartan 320mg Film-coated Tablets, PL 00289/1238

BATCH NUMBER EXPIRY DATE PACK SIZE DATE OF FIRST DISTRIBUTION
100433 28/02/2019 1 x 28 21/06/2017
101777 31/07/2019 1 x 28 15/01/2018

Valsartan 40mg Film-coated Tablets, PL 00289/1235

BATCH NUMBER EXPIRY DATE PACK SIZE DATE OF FIRST DISTRIBUTION
100350 28/02/2019 1 x 7 01/06/2017
100938 30/04/2019 1 x 7 03/01/2018
101776 31/08/2019 1 x 7 13/09/2018

Valsartan / Hydrochlorothiazide 80 / 12.5mg Film-coated Tablets, PL 00289/1233

BATCH NUMBER EXPIRY DATE PACK SIZE DATE OF FIRST DISTRIBUTION
6P601163 31/01/2019 1 x 28 23/06/2016
6P606333 30/06/2019 1 x 28 07/10/2016
0001584 31/12/2019 1 x 28 26/04/2017
0002626 31/03/2020 1 x 28 25/08/2017
0002627 31/03/2020 1 x 28 05/07/2017
0003214 30/04/2020 1 x 28 30/10/2017
0004744 31/08/2020 1 x 28 27/12/2017

Valsartan / Hydrochlorothiazide 160 / 12.5mg Film-coated Tablets, PL 00289/1215

BATCH NUMBER EXPIRY DATE PACK SIZE DATE OF FIRST DISTRIBUTION
6P607166 31/07/2019 1 x 28 07/10/2016
0000426 30/09/2019 1 x 28 13/02/2017
0001520 31/12/2019 1 x 28 04/05/2017
0001521 31/12/2019 1 x 28 25/05/2017
0002298 29/02/2020 1 x 28 16/08/2017
0003663 31/05/2020 1 x 28 27/09/2017
0004670 31/08/2020 1 x 28 11/12/2017

Valsartan / Hydrochlorothiazide 160 / 25mg Film-coated Tablets, PL 00289/1234

BATCH NUMBER EXPIRY DATE PACK SIZE DATE OF FIRST DISTRIBUTION
6P601084 31/01/2019 1 x 28 19/05/2016
6P606270 30/06/2019 1 x 28 13/09/2016
0000350 30/09/2019 1 x 28 23/01/2017
0000352 30/09/2019 1 x 28 12/04/2017
0001997 31/01/2020 1 x 28 12/06/2017
0002338 29/02/2020 1 x 28 16/08/2017
0003615 31/05/2020 1 x 28 27/09/2017

Mylan

MEDLINE PRODUCT PL NUMBER
Valsartan 40mg Capsules PL 04569/1000
Valsartan 80mg Capsules PL 04569/1001
Valsartan 160mg Capsules PL 04569/1002
Valsartan 40mg Film-coated Tablets PL 04569/1175
Valsartan 320mg Film-coated Tablets PL 04569/1178

Further to Drug Alert number EL (18) A/11, issued in July 2018 in connection with Valsartan containing products contaminated with N-nitrosodimethylamine (NDMA), we have become aware of another nitrosamine contaminant in batches of Valsartan active substance.

This contaminant is N‑nitrosodiethylamine (NDEA), which also has genotoxic and carcinogenic potential. Valsartan containing products from UK suppliers Teva UK Limited and Mylan are affected.

Teva is recalling the listed batches and Mylan is recalling all unexpired batches of the above products from pharmacies as a precautionary measure at a European level due to possible contamination with NDEA.

Healthcare Professionals and wholesalers

  • Stop supplying the above products / batches listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
  • If you receive queries about this issue from patients, advise them not to stop taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment.
  • We do not anticipate any shortages of Valsartan containing products. It is possible, however, that there may be some local supply issues, in which case patients should be advised to speak to their doctor to discuss alternative treatments.

This is a developing issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses.

Company contacts for further information

Teva UK Limited

For stock control:general.enquiries@tevauk.com

For medical information enquiries: medinfo@tevauk.com

Mylan

For stock control: mguk_customer.services@mylan.co.uk, 01707 853100

For medical information enquiries:info@mylan.co.uk, 01707 853 000, Option 1

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

MHRA recalls Valsartan blood pressure and heart medication from pharmacies

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UK pharmacies are assisting with the precautionary recall of Valsartan medication.

Valsartan recall image

The Medicines and Healthcare products Regulatory Agency (MHRA) are undertaking a pharmacy level recall of all affected batches of Valsartan containing medicines made by Mylan and Teva as a precautionary measure.

This follows an earlier pharmacy level recall in July, when MHRA recalled affected batches of valsartan containing medicines from Dexcel and Actavis (now Accord), also to pharmacy level.

That recall occurred across Europe, following information that an impurity, N-nitrosodimethylamine (NDMA) was identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China.

During the course of the investigation into NDMA, another impurity, N-nitrosodiethylamine (NDEA), was discovered in valsartan drug substance. MHRA, together with other EU regulators, are continuing to investigate other sartan products which share a similar chemical structure to valsartan.

At present there is no evidence that this impurity has caused any harm to patients. This recall is being undertaken as a precautionary measure to prevent further exposure to this impurity in the affected medicines whilst the investigation is ongoing. Due to the risk associated with suddenly stopping high blood pressure medication, people are therefore advised not to stop any treatments without consulting their doctor or pharmacist.

We are working closely with other EU member states, the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM) to ensure a thorough investigation and we will consider the impact in the UK and what actions may be necessary.

(SOURCE – MHRA)

EDQM suspend Mylan laboratories Valsartan license

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Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India.

European Directorate for the Quality of Medicines has now suspended the manufacturer’s CEP, effectively prohibiting the use of its valsartan in EU medicines.

In addition, national authorities in the EU have started recalling affected batches of medicines containing Mylan’s valsartan and are conducting further tests to determine the extent of the contamination.

NDEA and the related compound N-nitrosodimethylamine (NDMA), which have been seen in ‘sartans’ from other manufacturers, are classified as probable human carcinogens (substances that could cause cancer).

Companies marketing sartan medicines in the EU have been asked to test their products for these impurities. Additional testing is being carried out by EU laboratories. The European Medicines Agency will update the public as soon as new information becomes available.

 

Source: EMA

 

Theft of medicines: Gabapentin Noumed 300mg Capsules, Alvesco AZ

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Silverdale Healthcare Ltd has recently been informed of the theft of a quantity of the following medicine(s):

Ref: INC 13796

 

Date of incident: 17 July 2018

Manufacturer: Noumed Life Sciences Limited

Product: Gabapentin Noumed 300mg Capsules

 

Details of the missing medicines are listed below:

 

Product Description PL No. Batch No. Exipry Date Quantity Missing (Cartons)
Gabapentin

Noumed,300mg

Capsules

PL 44041/0020

 

4A0235

4A0236

4A0237

March 2020

March 2020

March 2020

4422

3456

960

 

The following has also been subject to being stolen:

Ref: INC 13780

Date of incident: 16/07/2018

MA holder is Astra Zeneca UK Ltd

Product: 18 units of Alvesco (see table below)

PL 17901/0297-0298

 

Batch details are as follows – Two units from each batch were in the two boxes in question – Total of

18 units:

Batch Product Desciption Expiry
     
GTE017A Alvesco P&B 160mcg 120D Austra 7CI312LFC 09.04.2021
GSL014B Alvesco P&B 160mcg 60D Neth 7CI306LHA 06.11.2020
GTC037D Alvesco P&B 80mcg 60D Russia 7CI206LRU 13.03.2021
GTC034G Alvesco P&B 80mcg 120D Sloven 7CI212LSL 01.02.2021
GTC037C Alvesco P&B 80mcg 60D France 7CI206LMF 12.02.2021
GSL014A Alvesco P&B 160mcg 60D Spain 7CI306LSP 06.11.2020
GTC035A Alvesco P&B 160mcg 60D Poland 7CI306LPO 01.02.2021
GTC059B Alvesco P&B 160mcg 60D Czech 7CI306LCK 24.02.2021
GTA122D Alvesco P&B 160mcg 120D Fin 7CI312LRA 28.12.2020

 

Source – MHRA

Class 1 Medicines Recall: Action Now – including out of hours Pharmacy Level Recall

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Pharmacies in the UK are being advised to recall all batches of valsartan containing medicines made by Actavis Group PTC (now Accord), Aptil Pharma Limited (now Torrent) and Dexcel Pharma Ltd due to contamination.

Brief description of the problem

All batches of the above products are being recalled at a European level due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Product details

Product Name Marketing Authorisation Holder PL number
VALSARTAN 40MG CAPSULES, HARD DEXCEL PHARMA LIMITED PL 14017/0192
VALSARTAN 80MG CAPSULES, HARD DEXCEL PHARMA LIMITED PL 14017/0193
VALSARTAN 160MG CAPSULES, HARD DEXCEL PHARMA LIMITED PL 14017/0194
VALSARTAN 40MG FILM-COATED TABLETS ACTAVIS GROUP PTC EHF PL 30306/0109
VALSARTAN 80MG FILM-COATED TABLETS ACTAVIS GROUP PTC EHF PL 30306/0110
VALSARTAN 160MG FILM-COATED TABLETS ACTAVIS GROUP PTC EHF PL 30306/0111
VALSARTAN 320MG FILM-COATED TABLETS ACTAVIS GROUP PTC EHF PL 30306/0405

Healthcare professionals and wholesalers

Stop dispensing the products listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. An investigation into other potentially impacted products is currently being undertaken and further updates will be provided as the investigation progresses.

Class 2 Medicines Recall:Own-brand children’s glycerine and blackcurrant cough syrups manufactured by Bell, Sons & Co.

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Bell, Sons & Co is recalling several batches of own-brand children’s blackcurrant cough syrups due to a small number of reports of mould.

Product information

Company name

Bell, Sons & Co.

Product description

Asda Children’s Dry Cough Syrup Glycerol Blackcurrant Flavour;

Bell’s Healthcare Children’s Dry Cough Glycerin 0.75g/5ml Syrup;

Morrisons Children’s Dry Tickly Cough Glycerin 0.75g/5ml Oral Solution;

Numark Children’s Dry Cough 0.75 g/5 ml Oral Solution;

Sainsbury’s Children’s Dry Cough 0.75g/5ml Syrup;

Superdrug Children’s Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution;

Tesco Children’s Dry Cough Syrup;

Wilko Tickly Cough 0.75g/5ml Oral Solution

Brand & Product Description Batch Number D Code Expiry Date Pack Size Date Released
Asda Children’s Dry Cough Syrup Glycerol Blackcurrant Flavour 274V1 D10-5120 01-Aug-2020 200 ml 27/09/2017
Asda Children’s Dry Cough Syrup Glycerol Blackcurrant Flavour 276V1 D10-5120 01-Oct-2020 200 ml 31/10/2017
Asda Children’s Dry Cough Syrup Glycerol Blackcurrant Flavour 278V1 D10-5120 01-Dec-2020 200 ml 02/01/2018
Asda Children’s Dry Cough Syrup Glycerol Blackcurrant Flavour 283W1 D10-5120 01-Feb-2021 200 ml 19/02/2018
Bell’s Healthcare Children’s Dry Cough Glycerin 0.75g/5ml Syrup 280V3 D10-4315 01-Dec-2020 200 ml 04/01/2018
Morrisons Children’s Dry Tickly Cough Glycerin 0.75g/5ml Oral Solution 282W1 D10-4325 01-Jan-2021 200 ml 30/01/2018
Numark Children’s Dry Cough 0.75 g/5 ml Oral Solution 280V1 D10-4042 01-Dec-2020 200 ml 04/01/2018
Numark Children’s Dry Cough 0.75 g/5 ml Oral Solution 288W1 D10-4042 01-Apr-2021 200 ml 27/04/2018
Sainsbury’s Children’s Dry Cough 0.75g/5ml Syrup 275V1 D10-0112 01-Sep-2020 200 ml 11/10/2017
Superdrug Children’s Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution 280V2 D10-4695 01-Dec-2020 200 ml 04/01/2018
Superdrug Children’s Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution 284W1 D10-4695 01-Mar-2021 200 ml 24/03/2018
Tesco Children’s Dry Cough Syrup 277V1 D10-4271 01-Oct-2020 200 ml 31/10/2017
Tesco Children’s Dry Cough Syrup 278V2 D10-4271 01-Dec-2020 200 ml 02/01/2018
Tesco Children’s Dry Cough Syrup 281W1 D10-4271 01-Jan-2021 200 ml 30/01/2018
Wilko Tickly Cough 0.75g/5ml Oral Solution 275V2 D10-0310 01-Sep-2020 200 ml 11/10/2017

Brief description of the problem

Bell, Sons & Co (Bells) is recalling 15 batches of the cough syrups listed above to patient-level as a precautionary measure due to a small number of reports of mould.

Advice for healthcare professionals

This Drug Alert is provided to healthcare professionals for information in case you receive any queries or ADRs relating to this issue.

This is a GSL product which has been sold from the retail shops Tesco, Asda, Wilkos, Sainsbury, Morrisons, Superdrug in the retailer’s livery and one pharmacy chain (Numark, in Numark livery). It has also been supplied in Bell, Sons & Co livery to Poundstretcher and to a number of wholesalers. All retailers and wholesale customers have been notified and stock is already being recalled at store level. Patients are being asked to return bottles from the above batches to the shop they bought it from.

At the time of writing the MHRA has not received any reports of ADRs relating to this issue.

The mould has been identified as Penicillium decumbens, Penicillium corylophilum and Penicillium brevicompactum. Although these moulds may be inactivated in the stomach, there is a low potential risk of systemic infection in younger or immunocompromised children, causing symptoms of infection such as fever.

Penicillium brevicompactum and Penicillium corylophilum can produce mycotoxins. Reactions to these mycotoxins are rare in reported literature but there is a low risk they could induce non-specific toxin reactions that could include rashes, breathing difficulties and Gastro-Intestinal (GI) symptoms.

There is also a low risk of allergen-mediated disease either through inhalation or ingestion of Penicillium antigens to occur, causing allergic symptoms.

Grocery stores and Numark Pharmacies

Please quarantine and return all stock of this product to your supplier as per the instructions provided by Bell, Sons & Co If your customers return stock to you, please return it to your supplier.

Patients and parents

It is important for people to check if they have any bottles from the batches of the blackcurrant cough syrups listed above. If they do, they should not take them or give them to others. They should return any bottles of the batches above to the shop or pharmacy they bought it from. The mould is not always visible so they should return any bottles of the cough syrups from the batches above even if they can’t see the mould.

Whilst the possibility of a reaction to the mould is low, if parents are concerned their child has had a reaction they should speak to their GP, pharmacist or other healthcare professional.

As with any medicine, we strongly encourage anyone to report any suspected side effects to the MHRA via the Yellow Card Scheme.

Class 4 medicines defect information: Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU PL 16508/0046

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Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)

Product information

MDR number

MDR 147-09/17

Company name

Kyowa Kirin

Product description

Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU (Bleomycin sulfate)

PL number

PL 16508/0046

Batch number Expiry date Pack size First distributed
Y7B290 Oct 2020 10 Jun 2018

Brief description of the problem

In April 2017, glass particles were detected in a batch of Bleo-Medac (bleomycin sulfate) from the same manufacturer.

Advice for healthcare professionals

While investigations are ongoing, additional measures should be adopted:

  • follow all the recommended steps for the preparation of Bleo-Kyowa in accordance with the Summary of Product Characteristics
  • carefully inspect the reconstituted product under a bright light
  • if particulate or glass matter is visible after reconstitution, do not administer the product to patients. Please retain the vial, quarantined safely away from other stock and notify the marketing authorisation holder
  • if there is no visible particulate matter after reconstitution, the use of a standard 5-micron (5 µm) filter needle to withdraw the reconstituted product from the vial prior to administration is recommended as glass particles may be difficult to see

Background

In April 2017, reports of glass particles in a batch of Bleo-Medac Powder for Solution for Injection, 15,000 IU, resulted in recall in some European countries. No recall action was necessary in the UK as the affected batch had not been distributed in the UK.

The marketing authorisation holder continues to investigate the root cause of this quality defect. To maintain continuity of supply in the UK, the marketing authorisation holder will distribute new batches of Bleo-Kyowa that meet current specifications.

Company contact information

Kyowa Kirin Medical Information

Tel: +44 (0)1896 664000

medinfo@kyowakirin.com

Merck sells consumer healthcare unit to P&G

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Germany’s Merck is selling its consumer health unit to Procter & Gamble for around for 3.4 billion Euros.

Merck said last year that is was mulling over the future of its consumer health division, and that a sale would help it execute its science and technology focused strategy.

“Consumer Health is a strong business that deserves the best possible opportunities for its future development. With P&G we have found a strong, highly recognised player who has the necessary scale to successfully drive the business going forward.”

Merck said sales from its consumer health unit grew organically by 6 percent between 2015 and 2017, “outpacing the consumer health market’s growth of approximately 4 percent over the same period”. The business pulled in new sales of around $911 million last year.

The transaction, which is expected to close by the end of the fourth quarter 2018, is subject to regulatory approvals and other customary closing conditions.

 

Source- Pharma Times

Diabetes test strips recalled in new alert

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Strips Recall

People with diabetes are advised to stop using and return specific lots of Accu-Chek Aviva and Accu-Chek Performa test strips following a recent recall by the manufacturer.

Accu-Chek Inform II test strips have also been recalled but are supplied in the UK by Roche for professional use only.

The test strips, commonly used by diabetics for blood glucose testing, may give increased strip error messages prior to dosing with blood and in some cases may give falsely high or low readings which may be hard to detect.

The Medicines and Healthcare products Regulatory Agency (MHRA) are urging users to check the lot numbers of their test strips against the lot numbers listed in the table below. More information can be found in this field safety notice. It is estimated that more than 260,000 packs have been affected.

If anyone finds they have test strips from the affected lots, they are advised to seek alternative testing methods and return affected lots to their pharmacy or shop where they will be offered a replacement.

It is also advised anyone with concerns about their blood glucose readings should discuss this with a healthcare professional.

Affected products

ACCU-CHEK AVIVA STRIPS (50s)

  • 497392
  • 497391
  • 496915
  • 496809
  • 496802
  • 496807

ACCU-CHEK AVIVA STRIPS (10s)

  • 497344
  • 497392

ACCU-CHEK PERFORMA STRIPS (10s)

  • 476597
  • 476646

Accu-Chek Inform II strips (professional use only)

  • 476614

Accu-Chek Performa Nano mmol Kit

(Please note the FSN only applies to the pack of Performa 10 test strips contained within the kit)

  • 10153116
  • 10153114
  • 10153115
  • 10153112
  • 10153111

Dan Howarth, Head of Care at Diabetes UK said:
It is incredibly important that people living with diabetes are able to rely on the technology that is designed to help them manage their blood sugar, so we’d strongly recommend that anyone using these test strips check their batch numbers and get replacement strips accordingly.

Inaccurate readings could mean you over- or under-dose with insulin, which in the short term can cause problems with hyper and hypoglycaemia. If you’re worried about your readings, we’d recommend speaking to your GP or a pharmacist as soon as possible.

Class 3 Medicines Recall: Latanoprost Timolol Eye drops

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FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)

MDR number

MDR 076-04/18

Company name

FDC Pharma

Product description

Latanoprost / Timolol 50 micrograms/mL + 5mg/mL

Eye Drops, Solution

PL 35638/0004

Batch number/expiry

Batch Number Expiry Date Pack Size First Distribution
087B087 01/2019 1 x 2.5 mL 15/06/2017

Brief description of the problem

FDC Pharma are recalling the above batch due to an out of specification result for an unknown impurity during stability testing.

Advice for healthcare professionals

Stop dispensing the batch listed above. Quarantine and return all remaining stock of this batch to your supplier using the supplier’s approved process.

Advice for wholesalers and distributors

Refer to the instructions provided by FDC Pharma. Stop distributing the batch listed above. Quarantine and return all remaining stock of this batch to your supplier using the supplier’s approved process.