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02 Dec 2019

CLH Blog - MHRA Field Safety Updates For November 2019

CLH Blog - MHRA Field Safety Updates For November 2019

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it is vital that you act on it immediately.

Class 2 Medicines recall: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (EL(19)A/39) - Urgent Recall

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerede Adrenaline Autoinjectors after identifying an error than can cause some pens to fail to activate.

Brief description of the problem
Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of the above product due to an error in one component of the autoinjector believed to cause some pens to fail to activate and deliver adrenaline. More information is provided in attachment below.

Emerade stock held by patients is not being recalled, and patients and caregivers in possession of Emerade pens need to be informed of updated safety information about the risk of failure to activate.

Advice for healthcare professionals
Stop supplying the above product immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Healthcare professionals are urged to share the additional information below with all patients and carers who have been prescribed an Emerade pen.

FSN date: November 2019

Class 2 Medicines Recall: M&A Pharmachem Limited Paracetamol 500 mg Tablets, 1 x 1000, PL 04077/0001, EL(19)A/38 - Urgent Recall 

M&A Pharmachem Limited is recalling all unexpired batches as a precautionary measure, because a small number of pots from some batches have been found to contain discoloured tablets due to fungal contamination.

Brief description of the problem:

M & A Pharmachem is recalling all unexpired batches as a precautionary measure, because a small number of pots from some batches have been found to contain discoloured tablets due to fungal contamination. The fungus has been identified as Penicillium citrinum. It is unlikely that any affected tablets will have got to patient level as the discolouration is noticeable on opening affected packs.

Advice for healthcare professionals:

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

FSN date: November 2019

Class 2 Medicines recall: Ranitidine 75mg Tablets, (Various Liveries) (EL(19)A/37) - Urgent Recall 

OTC Concepts Ltd, Relonchem Ltd, Noumed Life Sciences Ltd and Medreich Plc. are recalling stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.

Product information:

PL number
OTC Concepts Limited

  • Ranitidine 75mg Tablets: PL 20338/0020
  • Relonchem Limited
  • Relonchem Ranitidine 75mg Tablets (6): PL 20395/0079
  • Relonchem Ranitidine 75mg Tablets (12): PL 20395/0079
  • Bells Healthcare Ranitidine 75mg Tablets (12): PL 20395/0079
  • Numark Ranitidine 75mg Film Coted Tablets (12): PL 20395/0079
  • Tesco Heartburn and Indigestion Relief 75mg Film Coated Tablets (12): PL 20395/0079
  • Noumed Life Sciences Limited
  • Noumed Indigestion Relief 75mg Film-Coated Tablets: PL 44041/0027
  • Gavilast Heartburn and Indigestion 75mg Film-Coated Tablets: PL 44041/0028
  • Ranitidine 75mg Film-Coated Tablets: PL 44041/0028
  • Medreich PLC
  • ASDA Ranitidine 75 mg Tablets (12): PL 21880/0022
  • Peach Ethical Indigestion Relief Ranitidine 75mg Film Coated Tablets (12): PL 21880/0022
  • Sainsbury’s Indigestion Relief Tablets (12): PL 21880/0022
  • Tesco Indigestion Relief Ranitidine 75mg film-coated tablets: PL 21880/0022

MDR Number: MDR 56-09/19

FSN date: November 2019

Class 2 Medicines Recall: Sandoz Limited, Omeprazole 40 mg Powder for Solution for Infusion, PL 04416/0701 (EL(19)A/34) - Field Safety Notice

Sandoz Limited is recalling one batch due to the occurrence of degradation in some vials, resulting in green discoloration of the powder in the vial, leading to increased levels of impurities/degradation products in the medicine.

Brief description of the problem:

Sandoz Limited is recalling the above batch due to the occurrence of degradation in some vials, resulting in green discoloration of the powder in the vial, leading to increased levels of impurities/degradation products in the medicine. The manufacturer has confirmed the root cause to be an extended exposure to a UV light located within the warehouse and this only affects the batch listed above.

Advice for healthcare professionals:

Please quarantine all remaining stock of the above batch and return it to your original supplier using your supplier’s approved process.

FSN date: November 2019

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