Class 4 Medicines Defect Information, Ayrton Saunders Limited, Beclometasone dipropionate 50micrograms/dose Nasal Spray (Various Liveries), EL(22)A/14
MDR Number: MDR 087-03/22
Company name: Ayrton Saunders Limited
Product description:
Careway Hayfever Relief 50 micrograms/dose Nasal Spray PL 16431/0121
Details of the affected batch:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
9F713 |
May 2022 |
200 dose |
28th June 2019 |
|
9K772 |
September 2022 |
200 dose |
5th November 2019 |
Details of the affected batch:
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 |
30th September 2019 |
Details of the affected batch:
Lloyds Pharmacy Hayfever Relief 50micrograms/dose Nasal Spray PL 16431/0121
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
1B978 |
January 2024 |
200 doses |
16th March 2021 |
|
9H744 |
July 2022 |
200 doses |
16th September 2019 |
|
0F900 |
May 2023 |
200 doses |
16th July 2020 |
Details of the affected batch:
Tesco Allergy Relief 50 micrograms/dose Nasal Spray PL 16431/0121
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
0G913 |
June 2023 |
200 doses |
27th August 2020 |
|
1C988 |
February 2024 |
200 doses |
31st March 2021 |
|
1B979 |
January 2024 |
200 doses |
22nd March 2021 |
Brief description of 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 to 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.
Company contacts for further information:
For medical information and stock control queries please contact: Ayrton Saunders Ltd., 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU or quality@ayrtons.com
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
To access the full recall: