Class 4 Medicines Defect Information: Mometasone Furoate 50 Microgram / Dose Nasal Spray, Suspension, PilsCo Ltd, EL (21)A/33
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
Details of the affected batches:
|
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 |
Brief description of 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 to 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.
Company contacts for further information:
For more information, medical information queries or stock control queries, please contact:
Nigel Kelly Nigel@ethigen.co.uk 013555 98155
To access the full recall: Class 4 Medicines Defect Information: Mometasone Furoate 50 Microgram / Dose Nasal Spray, Suspension, PilsCo Ltd, EL (21)A/33