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MHRA recalls Beconase Aqueous Nasal Spray, Gliclazide 40 mg tablets

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The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 FMD medicines recall for Beconase Aqueous Nasal Spray and a class 2 pharmacy level recall for Gliclazide 40 mg Tablets.

Glaxo Wellcome UK Ltd T/A GSK is recalling the Beconase Aqueous Nasal Spray with batch number K84X, due to an issue related to error in the decommissioning.

This is the first falsified medicine directive (FMD) recall since July 2019.

“Upon decommissioning at the pharmacy and when scanning the serialised 2D code, the status of packs may report as ‘DESTROYED’,” the MHRA statement read.

Batch Number Expiry Date Pack Size First Distributed
K84X 09-2021 1 06-Jan-2020

Accord UK is recalling all unexpired stock of Gliclazide 40 mg Tablets in Northstar Livery with batch number GU50 from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution, obtained during routine stability testing.

Batch Number Expiry Date Pack Size First Distributed
GU50 Dec 2020 28 24/05/2019

Pharmacists are asked to stop supplying both products immediately, quarantine remaining stock and return it to the supplier using the approved process.

The government agency also issued a class 4 pharmacy level caution in use for 13 batches of Atrolak (Quetiapine) prolonged release tablets by Accord, as the Patient Information Leaflet (PIL) within the packs are missing the side effects identified from post-marketing experience.

Pharmacists are adviced to ensure that patients are of any missing information and issue the current PILs with special warnings and precautions while dispensing the product.

Atrolak XL 50mg prolonged release tablets PL 20075/0213

Batch Number Expiry Date Pack Size First Distributed
322729 05/2021 60 19 December 2019
Y06455 10/2021 60 03 September 2019

Atrolak XL 150mg prolonged release tablets PL 20075/0446

Batch Number Expiry Date Pack Size First Distributed
Y04771 10/2021 60 06 November 2019
Y04788 10/2021 60 27 September 2019
Y02374 05/2021 60 07 August 2019

Atrolak XL 200mg prolonged release tablets PL 20075/0214

Batch Number Expiry Date Pack Size First Distributed
X17653 02/2021 60 24 November 2019
Y06710 08/2021 60 18 November 2019

Atrolak XL 300mg prolonged release tablets PL 20075/0215

Batch Number Expiry Date Pack Size First Distributed
Y06909 09/2021 60 04 October 2019
X21602 05/2021 60 07 April 2019
X19649 03/2021 60 03 July 2019
X19866 03/2021 60 11 June 2019

Atrolak XL 400mg prolonged release tablets PL 20075/0216

Batch Number Expiry Date Pack Size First Distributed
X21825 05/2021 60 10 October 2019
X18765 03/2021 60 05 July 2019

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