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Class 4 Medicines Defect Information: Mometasone Furoate 50 Microgram / Dose Nasal Spray, Suspension, PilsCo Ltd, EL (21)A/33

Published On:

29 November 2021

Published In:

Error relating to the wording on the outer carton label for Mometasone Furoate 50 Microgram / Dose Nasal Spray, supplied by PilsCo Ltd.

MDR Number

MDR 282-11/21

Company name

PilsCo Ltd.

Product description

Mometasone Furoate 50 Microgram / Dose Nasal Spray, Suspension

Batch No Expiry Date Pack Size First Distributed
KT1782 31/05/2022 Bottle 18g, corresponding to 140 delivered doses 03/02/2021
KT1781 31/05/2022 Bottle 18g, corresponding to 140 delivered doses 31/03/2021
KV4290 31/07/2022 Bottle 18g, corresponding to 140 delivered doses 12/05/2021
KV4303 31/07/2022 Bottle 18g, corresponding to 140 delivered doses 13/05/2021
KR4651 31/05/2022 Bottle 18g, corresponding to 140 delivered doses 13/05/2021
KV4301 31/07/2022 Bottle 18g, corresponding to 140 delivered doses 25/05/2021
KV4299 31/07/2022 Bottle 18g, corresponding to 140 delivered doses 04/06/2021
KV4302 31/07/2022 Bottle 18g, corresponding to 140 delivered doses 05/07/2021
KY6352 30/09/2022 Bottle 18g, corresponding to 140 delivered doses 13/07/2021
KY6322 30/09/2022 Bottle 18g, corresponding to 140 delivered doses 31/08/2021

Active Pharmaceutical Ingredient: Mometasone Furoate

Brief description of the problem

PilsCo Ltd. have identified a error relating to the wording on the outer carton label. The label affixed on the bottle states: ‘use within 2 weeks of first use’, instead of the correct label statement which should be: ‘use within 2 months of first use’.

The correct statement ‘use within 2 months of first use’ is printed on the patient information leaflet and on the carton.

Advice for healthcare professionals

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and instruct the patient to ensure they use the product within 2 months of first use.

Further Information

For more information, medical information queries or stock control queries, please contact:

Nigel Kelly

[email protected]

013555 98155

For the full article and to download the accompanying document please click HERE

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