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Understanding Risk and Compliance in Health and Social Care

Class 4 Medicines Defect Information, Ayrton Saunders Limited, Beclometasone dipropionate 50 micrograms/dose Nasal Spray (Various Liveries), EL (22)A/14

Published On:

15 March 2022

Published In:

Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.

MDR Number

MDR 087-03/22

Company name

Ayrton Saunders Limited

Product description

Careway Hayfever Relief 50 micrograms/dose Nasal Spray PL 16431/0121

Batch Number Expiry Date Pack Size First Distributed
9F713 May 2022 200 doses 28 June 2019
9K772 September 2022 200 doses 5 November 2019

Careway Hayfever Relief for Adults 50 micrograms/dose Nasal Spray PL 16431/0176

Batch Number Expiry Date Pack Size First Distributed
9J739 August 2022 100 doses 30 September 2019

Lloyds Pharmacy Hayfever Relief 50 micrograms/dose Nasal Spray PL 16431/0121

Batch Number Expiry Date Pack Size First Distributed
1B978 January 2024 200 doses 16 March 2021
9H744 July 2022 200 doses 16 September 2019
0F900 May 2023 200 doses 16 July 2020

Tesco Allergy Relief 50 micrograms/dose Nasal Spray PL 16431/0121

Batch Number Expiry Date Pack Size First Distributed
0G913 June 2023 200 doses 27 August 2020
1C988 February 2024 200 doses 31 March 2021
1B979 January 2024 200 doses 22 March 2021

Active Pharmaceutical Ingredient: Beclometasone dipropionate

Brief description of the problem

Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons. See Appendix 1 of the attached notification for detailed Braille information.

Careway Hayfever Relief 50 micrograms/dose Nasal Spray, PL 16431/0121

  • The Braille on the packaging reads EJ micrograms instead of 50 micrograms due to a space being included after the numerical indicator and ‘/dose’ is missing after the strength.

Careway Hayfever Relief for Adults 50 micrograms/dose Nasal Spray, PL 16431/0176

  • The packaging is missing ‘for Adults’ in the product name.

Lloyds Pharmacy Hayfever Relief 50 micrograms/dose Nasal Spray, PL 16431/0121

  • The Braille on the packaging reads EJ micrograms instead of 50 micrograms and lloydspharmacy has an error in the product name.

Tesco Allergy Relief 50 micrograms/dose Nasal Spray, PL 16431/0121

  • Tesco Allergy relief is missing the strength ’50 micrograms/dose’.

Advice for healthcare professionals

The impacted products are within specification and there is no issue with product quality. Therefore, the affected batches are not being recalled. Healthcare professionals should explain, if requested, the errors to patients who rely solely on Braille when reading medicine cartons. The products are supplied as a single strength therefore there are no possibilities of a dosing error occurring due to the error in the Braille.

To view the full article and download the document please click HERE

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