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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: Sayana Press 104mg/0.65ml (MDR 055-06/19)

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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

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)

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