Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
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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
UK pharmacies are assisting with the precautionary recall of Valsartan medication.
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)
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.
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)|
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)
Batch details are as follows – Two units from each batch were in the two boxes in question – Total of
|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
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 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.
Bell, Sons & Co is recalling several batches of own-brand children’s blackcurrant cough syrups due to a small number of reports of mould.
Bell, Sons & Co.
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.
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)
Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU (Bleomycin sulfate)
|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
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
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