Category Archives: News

Class 2 Medicines recall: Ranitidine 150mg/10ml Oral Solution (EL (19)A/29)

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Rosemont Pharmaceuticals Limited is recalling unexpired stock from pharmacies as a precautionary measure due to possible contamination with an impurity.

Product information

PL number

PL 00427/0132

MDR Number

MDR 56-09/19

Company name

Rosemont Pharmaceuticals Limited (part of the Perrigo group)

Product description

Ranitidine 150mg/10ml Oral Solution (PL 00427/0132)

Brief description of the problem

Rosemont Pharmaceuticals Limited is recalling all unexpired stock of the above products from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Advice for healthcare professionals

  • Stop supplying the above products 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.

This is an on-going 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.

 

Source – MHRA

Class 2 Medicines recall: Zantac Injection 50mg/2ml, Zantac Syrup 150mg/10ml, Zantac Tablets 150mg, Zantac Tablets 300mg (EL (19)A 24)

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GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.

Source – MHRA

Class 4 Medicines Defect Information: Prednisolone 5mg Tablets (MDR 61-04/19)

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Genesis Pharmaceuticals Ltd has informed us that there is an error on the Braille for the above batches which means that the strength reads as 1mg instead of 5mg. The printed text is correct on all packaging.

Product description
Prednisolone 5mg Tablets. PL 42967/0037.

Batch Number Expiry Date Pack Size First Distributed
1809653 08/2021 1 x 28 28/01/2019
1809654 08/2021 1 x 28 28/01/2019
1809655 08/2021 1 x 28 30/01/2019
1809656 08/2021 1 x 28 06/02/2019
1809657 08/2021 1 x 28 26/02/2019

Advice for healthcare professionals
There is a risk to patients who have compromised eye-sight and who rely solely on Braille to determine their tablet strength.

Packs from the above distributor with the above batch numbers should not be dispensed to patients who rely solely on Braille.

We understand that alternative batches of the product are available from a number of suppliers.

Further information
For further information, please contact Genesis Pharmaceuticals Ltd, on 020 7201 0400.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Ativan 4mg/1ml Solution for injection CLASS 4 MEDICINES DEFECT INFORMATION

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CLASS 4 MEDICINES DEFECT INFORMATION – Ativan 4mg/1ml Solution for injection

Dear Healthcare Professional, Pfizer Limited Ativan 4mg/1ml Solution for injection PL 00057/1279 (Lorazepam)

Batch Number Expiry Date Pack Size First Distributed

4091 Oct 2019 10 x 1ml 15 Apr 2019

4092 Dec 2019 10 x 1ml 10 Apr 2019

4094 Dec 2019 10 x 1ml NA

Pfizer Limited has informed us that the text on the carton label for the above product has recently been updated and at this time, the product description on the carton was changed from 10 x 1ml ampoules to 10 x 2ml ampoules. The updated text reflects the size of the ampoules, which is 2ml. The concentration and total volume of the ampoules has not changed and remains 4mg Lorazepam in 1ml of solution.
The size of the ampoules (2ml) has not changed and the label on the ampoules remains unchanged and states ‘4mg in 1ml’.

We understand that the carton label is in the process of being revised to reflect the volume of solution contained in the ampoules and batches with the revised labels are expected to become available during Q3 2019.
Further Information

Class 2 Medicines Recall: Actavis Group PTC EHF – recall of batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets

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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).

Actavis Group PTC EHF

Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets, PL 30306/0266

Batch number Expiry date Pack size Date of first distribution
059118 31/03/2020 1 x 28 17/09/2018
099218 31/03/2020 1 x 28 04/10/2018
191418 31/05/2020 1 x 28 25/10/2018

Irbesartan / Hydrochlorothiazide 150/12.5mg Film-coated Tablets, PL 30306/0265

Batch number Expiry date Pack size Date of first distribution
150118 30/04/2020 1 x 7 12/09/2018

Healthcare Professionals and wholesalers

  • Stop supplying the above 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 Irbesartan 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.

(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