Category Archives: News

Class 2 Medicines Recall: Esmya 5mg tablets

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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

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

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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.

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.