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Mar 29
0

Class 3 Medicines Recall: Thame Laboratories, Itraconazole 10mg/ml Oral Solution, EL (21)A/08

By | Other | No Comments

Class 3 Medicines Recall: Thame Laboratories, Itraconazole 10mg/ml Oral Solution, EL (21)A/08

 

PL Number(s)

PL 39307/0069

MDR Number

MDR 219-02/21

Company Name

Thame Laboratories

Product description

Itraconazole 10mg/ml Oral Solution

  • Batch number: L465
    • Expiry date: 03/2022
    • Pack size: 150 ml
    • First distributed: 25 Jan 2021
  • Batch number: L475
    • Expiry date: 03/2022
    • Pack size: 150 ml
    • First distributed: 25 Jan 2021

Active Pharmaceutical Ingredients: Itraconazole

Brief description of the problem

Thame Laboratories are recalling the above batches due to an issue with the container closure (child-resistant cap). The Marketing Authorisation Holder has received a number of complaints regarding the child-resistant caps which were difficult to open, and their investigation has identified an issue with the bottle capping process during the manufacture of the product.

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

 

Further Information

For more information or medical information queries, please contact customer.services@syrimed.co.uk

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice.

NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

 

Mar 29
0

List of medicines that cannot be exported from the UK or hoarded

By | Other | No Comments

List of medicines that cannot be exported from the UK or hoarded

Name Strength Pharmaceutical form Date of restriction
Aclidinium bromide All All 24/04/2020 00:00
Aclidinium bromide + Formoterol All All 24/04/2020 00:00
Adrenaline All Solution for injection 04/10/2019 00:00
Albumin human All All 23/03/2020 00:00
Alfentanil All Solution for injection 23/03/2020 00:00
Amikacin All Solution for injection 23/03/2020 00:00
Amiodarone All Oral solution, oral suspension 24/04/2020 00:00
Amiodarone All Solution for injection 23/03/2020 00:00
Amoxicillin All All 23/03/2020 00:00
Anakinra All Solution for injection 31/10/2020 00:00
Anidulafungin All All 23/03/2020 00:00
Argipressin All All 23/03/2020 00:00
Atenolol  All All 24/04/2020 00:00
Atracurium All All 23/03/2020 00:00
Azithromycin All Tablets, capsules 24/04/2020 00:00
Bambuterol All All 24/04/2020 00:00
Beclometasone All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Beclometasone + Formoterol All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Beclometasone + Formoterol + Glycopyrronium bromide All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Benralizumab All All 24/04/2020 00:00
Bisoprolol All Oral solution, oral suspension 24/04/2020 00:00
Budesonide All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Budesonide + Formoterol All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Buprenorphine All Patches 04/04/2020 00:00
Buprenorphine All All 24/04/2020 00:00
Calcium chloride All All 23/03/2020 00:00
Caspofungin All All 23/03/2020 00:00
Cefalexin All All 04/04/2020 00:00
Ceftazidime All Powder for solution for injection, intravenous infusion 23/03/2020 00:00
Ceftazidime + Avibactam All All 24/04/2020 00:00
Ceftriaxone All All 23/03/2020 00:00
Cefuroxime All Powder for injection 23/03/2020 00:00
Chloroquine phosphate All All 26/02/2020 00:00
Ciclesonide All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Cisatracurium All All 23/03/2020 00:00
Clarithromycin All All 23/03/2020 00:00
Clonidine All Tablets 23/03/2020 00:00
Co-amoxiclav All All 23/03/2020 00:00
Codeine All All 04/04/2020 00:00
Colestyramine All Oral powder sachets, oral powder sachets sugar free 05/12/2019 00:00
Co-trimoxazole All Solution for injection 04/04/2020 00:00
Cyclizine All Oral solution, oral suspension, solution for injection 23/03/2020 00:00
Dabigatran etexilate All All 07/11/2020 00:00
Dalteparin All All 23/03/2020 00:00
Dapagliflozin All All 24/04/2020 00:00
Dexamethasone All Tablets, capsules 24/04/2020 00:00
Dexamethasone All Oral solution, solution for injection 16/06/2020 00:00
Dexmedetomidine All All 23/03/2020 00:00
Diamorphine All Tablets 04/04/2020 00:00
Digoxin All Oral solution, oral suspension, solution for injection 24/04/2020 00:00
Dobutamine All All 23/03/2020 00:00
Edoxaban All All 04/04/2020 00:00
Epoprostenol All All 23/03/2020 00:00
Erythromycin All All 23/03/2020 00:00
Esmolol All All 23/03/2020 00:00
Esomeprazole All All 23/03/2020 00:00
Estradiol All All 04/10/2019 00:00
Estradiol + Levonorgestrel All All 04/10/2019 00:00
Estradiol + Norethisterone acetate All All 04/10/2019 00:00
Exenatide All All 24/04/2020 00:00
Fentanyl All Solution for injection 23/03/2020 00:00
Flucloxacillin All All 23/03/2020 00:00
Fluticasone All Inhaler, Inhalation powder, nebuliser liquid 05/12/2019 00:00
Fluticasone + Formoterol All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Fluticasone + Salmeterol All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Fluticasone + Umeclidinium bromide + Vilanterol All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Fluticasone + Vilanterol All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Formoterol All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Gentamicin All Solution for injection, infusion bags 23/03/2020 00:00
Glyceryl trinitrate All Solution for infusion 23/03/2020 00:00
Glycopyrronium bromide All Solution for injection 24/04/2020 00:00
Granisetron All Solution for injection 23/03/2020 00:00
Granisetron All Oral solution 24/04/2020 00:00
Haloperidol All Oral solution, oral suspension, solution for injection 24/04/2020 00:00
Heparin All All 23/03/2020 00:00
Hepatitis B vaccine All All 04/10/2019 00:00
Hydrocortisone Al Powder for solution for injection 23/03/2020 00:00
Hyoscine butylbromide All Solution for injection 24/04/2020 00:00
Ibuprofen All All 24/04/2020 00:00
Influenza vaccine All All 31/10/2020 00:00
Insulin aspart All All 04/04/2020 00:00
Insulin aspart biphasic All All 04/04/2020 00:00
Insulin degludec All All 04/04/2020 00:00
Insulin degludec + Liraglutide All All 04/04/2020 00:00
Insulin detemir All All 04/04/2020 00:00
Insulin glargine All All 04/04/2020 00:00
Insulin glargine + Lixisenatide All All 04/04/2020 00:00
Insulin glulisine All All 04/04/2020 00:00
Insulin human All All 23/03/2020 00:00
Insulin isophane biphasic human All All 04/04/2020 00:00
Insulin isophane biphasic porcine All All 04/04/2020 00:00
Insulin isophane bovine All All 04/04/2020 00:00
Insulin isophane human All All 04/04/2020 00:00
Insulin isophane porcine All All 04/04/2020 00:00
Insulin lispro All All 04/04/2020 00:00
Insulin lispro biphasic All All 04/04/2020 00:00
Insulin mixed bovine All All 04/04/2020 00:00
Insulin protamine zinc bovine All All 04/04/2020 00:00
Insulin soluble bovine All All 04/04/2020 00:00
Insulin soluble human All All 23/03/2020 00:00
Insulin soluble porcine All All 04/04/2020 00:00
Insulin zinc crystalline human All All 04/04/2020 00:00
Insulin zinc mixed human All All 04/04/2020 00:00
Ipratropium All All 04/04/2020 00:00
Ketamine All Solution for injection 23/03/2020 00:00
Labetalol All Oral solution, oral suspension, solution for injection 24/04/2020 00:00
Lansoprazole All Orodispersible tablets 23/03/2020 00:00
Levofloxacin All All 23/03/2020 00:00
Levomepromazine All All 04/04/2020 00:00
Linezolid All All 23/03/2020 00:00
Lisinopril All All 24/04/2020 00:00
Lithium carbonate All Tablets 08/09/2020 00:00
Lopinavir + Ritonavir All All 26/02/2020 00:00
Lorazepam All All 23/03/2020 00:00
Magnesium Sulfate All Solution for infusion, solution for injection 23/03/2020 00:00
Mesalazine All Suppositories 04/04/2020 00:00
Metaramino All All 24/04/2020 00:00
Metoclopramide All All 23/03/2020 00:00
Metoprolol All Oral solution, oral suspension, solution for injection 24/04/2020 00:00
Micafungin All All 23/03/2020 00:00
Midazolam All All 23/03/2020 00:00
Milrinone All All 23/03/2020 00:00
Mometasone All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Morphine All All 23/03/2020 00:00
Nedocromil All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Noradrenaline All Solution for infusion 23/03/2020 00:00
Norethisterone All All 18/10/2019 00:00
Ondansetron All Oral solution, oral suspension 24/03/2020 00:00
Ondansetron All Solution for injection 23/03/2020 00:00
Oseltamivir All All 04/10/2019 00:00
Oxycodone All All 23/03/2020 00:00
Pantoprazole All Oral suspension, powder for solution for injection 23/03/2020 00:00
Paracetamol All All 23/03/2020 00:00
Piperacillin + Tazobactam All All 23/03/2020 00:00
Plasma-Lyte All All 23/03/2020 00:00
Pneumococcal vaccine All All 06/11/2019 00:00
Potassium bicarbonate + Potassium chloride All All 23/03/2020 00:00
Potassium chloride All Solution for infusion, infusion bags 23/03/2020 00:00
Potassium chloride + Glucose + Sodium chloride All All 23/03/2020 00:00
Potassium chloride + Sodium chloride All All 23/03/2020 00:00
Prednisolone All Tablets, oral solution 23/03/2020 00:00
Prochlorperazine All All 04/04/2020 00:00
Propofol All All 23/03/2020 00:00
Ranitidine All All 18/10/2019 00:00
Remifentanil All All 23/03/2020 00:00
Rifampicin All Powder and solvent for solution for infusion 23/03/2020 00:00
Rivaroxaban All Tablets 04/10/2019 00:00
Rocuronium All All 23/03/2020 00:00
Roflumilast All All 24/04/2020 00:00
Ruxolitinib All All 24/04/2020 00:00
Salbutamol All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Salbutamol + Beclometasone All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Salbutamol + Ipratropium All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Salmeterol All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Sarilumab All All 24/04/2020 00:00
Semaglutide All Tablets 07/11/2020 00:00
Sodium chloride All Infusion, irrigation solution, solution for injection,nebuliser 23/03/2020 00:00
Sodium chloride All Inhalation solution 24/04/2020 00:00
Sodium cromoglicate All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Sodium cromoglicate + Salbutamol All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Sodium dihydrogen phosphate All All 23/03/2020 00:00
Sodium lactate All All 23/03/2020 00:00
Sodium zirconium cyclosilicate All All 24/04/2020 00:00
Suxamethonium All All 23/03/2020 00:00
Terbutaline All Inhaler, Inhalation powder, nebuliser liquid 04/04/2020 00:00
Terbutaline All All 24/04/2020 00:00
Terlipressin All All 23/03/2020 00:00
Ticagrelor All All 24/04/2020 00:00
Tinzaparin All All 23/03/2020 00:00
Tiotropium All All 24/04/2020 00:00
Tiotropium + Olodaterol All All 24/04/2020 00:00
Tocilizumab All All 24/04/2020 00:00
Vancomycin All All 23/03/2020 00:00
Voriconazole All All 23/03/2020 00:00

 

Mar 18
0

Class 2 Medicines Recall: Esmya 5mg tablets

By | News, UK Pharma | No Comments

Gedeon Richter (UK) Ltd is recalling all unexpired stock of the above products from patients, pharmacies and wholesalers following a new case of liver failure requiring liver transplant in a patient taking the medicine. To protect patients while a safety review is conducted, the European Medicines Agency’s safety committee, Pharmacovigilance Risk Assessment Committee, (PRAC) has recommended that women stop taking 5mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids.

Note: This recall does not affect the 30mg single dose ulipristal acetate emergency contraceptive products.

Advice for healthcare professionals

  • Contact patients who have been supplied Esmya and ask them to stop taking their medication as soon as possible and return any unused medicine to their pharmacy. All patients currently being treated with Esmya/ulipristal acetate for uterine fibroids should contact their doctor for advice about other possible treatments for uterine fibroids.
  • Stop supplying the above products immediately and remove from the shelves within your store. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
  • Stop prescribing Esmya or generic ulipristal acetate for the treatment of uterine fibroids. No new patients should start treatment with the medicines, which has been suspended throughout the EU during the review. Consider other treatment options as appropriate.
  • Liver function testing should be performed 2- 4 weeks after treatment has stopped as described in the product information for the medicines.
  • Healthcare professionals should alert patients to immediately report signs and symptoms of liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice) which could occur after stopping treatment.

 

Source – MHRA

Feb 20
0

Class 4 Drug Alert: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A/10)

By | News, UK Pharma | No Comments

Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect.

Brief description of the problem

The PIL in the above batches includes incorrect dosing instructions in Section 3, How to take Ibuprofen.

The leaflet incorrectly states that ‘The maximum daily dose should not exceed 6 [six] tablets (2400 mg).’

This dosing regimen should only be given to patients who are under the supervision of their GP or healthcare prescriber and have been prescribed Ibuprofen 400mg Tablets. The outer carton contains the correct P indications and posology.

Crescent Pharma Ltd products

Ibuprofen 400mg Tablets (Almus Livery) PL 20416/0089

Batch Number Expiry Date Pack Size First Distributed
DO3210N 09.2022 84 11 Jun 19
DO3310N 09.2022 84 07 Aug 19
DO3410N 09.2022 84 11 Jun 19
DO3510N 09.2022 84 11 Jun 19
DO3610N 10.2022 84 18 Jul 19
DO3710N 10.2022 84 12 Mar 19
DO3811N 10.2022 84 12 Mar 19
DO3911N 10.2022 84 19 Jul 19

Ibuprofen 400mg Tablets (Crescent Livery) PL 20416/0089

Batch Number Expiry Date Pack Size First Distributed
001205M 04.2021 84 08 Aug 19
DO0101O 12.2022 84 10.Jan 20
DO0503O 02.2023 84 10 Jan 20

Flamingo Pharma (UK) Ltd products

Ibuprofen 400mg Tablets (Flamingo Pharma Livery) PL 43461/0005

Batch Number Expiry Date Pack Size First Distributed
1402177 Aug-23 24 Oct-18
1402268 Sep-23 48 Nov-18
1402278 Oct-23 24 Dec-18
1402308 Nov-23 84 Dec-18
1402309 Nov-23 84 Dec-18
1402310 Nov-23 84 Dec-18
1402316 Nov-23 84 Jan-19
1402317 Nov-23 84 Jan-19
1402318 Dec-23 24 Jan-19
1402337 Dec-23 48 Jan-19
1402338 Dec-23 48 Jan-19
1402363 Dec-23 48 Mar-19
1402353 Dec-23 48 Mar-19
1402354 Dec-23 48 Mar-19
1402352 Dec-23 84 Mar-19
1402361 Dec-23 84 Mar-19
1402362 Dec-23 84 Mar-19
1402368 Jan-24 48 Mar-19
1402369 Jan-24 24 Mar-19
1402370 Jan-24 24 Mar-19
1402424 Mar-24 24 Apr-19
1402425 Mar-23 48 Apr-19
1402543 May-24 48 Jul-19
1402544 May-24 48 Jul-19
1402554 Jun-24 24 Jul-19
1402557 Jun-24 84 Aug-19
1402558 Jun-24 48 Aug-19
1402559 Jun-24 48 Aug-19
1402622 Jul-24 48 Sep-19
1402623 Jul-24 48 Sep-19
1402624 Jul-24 24 Sep-19
1402625 Jul-24 24 Sep-19
1402628 Jul-24 24 Sep-19
1402670 Aug-24 24 Nov-19
1402671 Aug-24 24 Nov-19
1402672 Aug-24 24 Nov-19
1402673 Aug-24 24 Nov-19
1402674 Sep-24 48 Nov-19
1402686 Sep-24 48 Nov-19
1402687 Sep-24 48 Nov-19
1402688 Sep-24 48 Nov-19
1402705 Sep-24 48 Nov-19
1402706 Sep-24 84 Nov-19
1402707 Oct-24 48 Dec-19
1402708 Oct-24 48 Dec-19
1402709 Oct-24 84 Dec-19
1402710 Oct-24 84 Dec-19
1402711 Nov-24 84 Jan-20
1402837 Dec-24 24 Feb-20
1402838 Dec-24 24 Feb-20
1402854 Dec-24 48 Feb-20
1402839 Dec-24 96 Feb-20
1402852 Dec-24 96 Feb-20
1402853 Dec-24 84 Feb-20

Ibuprofen 400mg Tablets (TEVA Livery) PL 43461/0005

Batch Number Expiry Date Pack Size First Distributed
1402172 Jul-23 84 Sep-18
1402173 Jul-23 84 Sep-18
1402174 Aug-23 84 Oct-18
1402175 Aug-23 84 Oct-18
1402176 Aug-23 84 Oct-18
1402178 Aug-23 84 Oct-18
1402279 Nov-23 84 Dec-18

Advice for healthcare professionals

When dispensing or providing this product over the counter, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of the correct dosage instructions and maximum daily dose as stated on the carton labelling.

Correct statement: The maximum daily dose should not be more than 3 tablets (1200 mg).

Where possible, these packs should be considered to be dispensed against a prescription rather than sold over the counter to safeguard patients from taking a prescription only dose.

Oct 28
0

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

By | News | No Comments

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

Oct 23
0

Class 2 Medicines recall: Sayana Press 104mg/0.65ml (MDR 055-06/19)

By | Other | No Comments

Pfizer Ltd is recalling certain batches of Sayana Press for subcutaneous injection.

Product information

PL number

PL 00057 / 1093

MDR Number

MDR 055-06/19

Company name

Pfizer Limited

Product description

Sayana Press 104mg/0.65ml, medroxyprogesterone acetate suspension for injection (PL 00057 / 1093)

Batch Number Expiry Date Pack Size First Distributed
L61367 31 January 2020 1 10 April 2015
L61367Y 31 January 2020 1 02 May 2016
T34580 31 July 2020 1 08 November 2017
X49124 30 June 2021 1 09 October 2018

Brief description of the problem

Pfizer Ltd has informed us of an issue related to the sealing process for some units of Sayana Press for subcutaneous (SC) injection potentially impacting the above listed batches. Sayana Press for subcutaneous (SC) injection is provided in a single-dose Uniject pre-filled injection system. During routine re-inspection of unreleased product batches, two related defects were observed;

  • injectors with moisture outside the sealed area with a wet label, immediately after their removal from the pouch
  • injectors with a temporarily unreadable expiry date on the unit label

The root cause analysis shows that the leak was attributed to a failure in the sealing process of the injection system and may impact the integrity of the product. Pfizer’s health assessment of the issue concluded that the use of the impacted product has an unlikely probability of being associated with adverse events and the potential risk to patients is considered to be negligible.

 

Source ~ MHRA

Oct 08
0

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

By | News, UK Pharma | No Comments

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

Product information

GlaxoSmithKline is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Product PL Number
Zantac Syrup 150mg/10ml 10949/0108
Zantac Injection 50mg/2ml 10949/0109
Zantac Tablets 150mg 10949/0042
Zantac Tablets 300mg 10949/0043

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 ongoing 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

Apr 26
0

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

By | News | No Comments

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.

Apr 25
0

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

By | News | No Comments

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

Jan 03
0

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

By | News | No Comments

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)