MHRA Class 4 Medicines Defect Information: Mometasone Furoate 50 microgram/Dose Nasal Spray
Class 4 Medicines Defect Information: Mometasone Furoate 50 Microgram / Dose Nasal Spray, Suspension, PilsCo Ltd
Drug alert number: EL (22)A/33
Date issued: 29 November 2021
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
Mometasone Furoate 50 Microgram / Dose Nasal Spray, Suspension, PilsCo Ltd
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.
Active Pharmaceutical Ingredient: Mometasone Furoate
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| KT1782 | 31/05/2022 | 18g = 140 delivered doses | 03/02/2021 |
| KT1781 | 31/05/2022 | 18g = 140 delivered doses | 31/03/2021 |
| KV4290 | 31/07/2022 | 18g = 140 delivered doses | 12/05/2021 |
| KV4303 | 31/07/2022 | 18g = 140 delivered doses | 13/05/2021 |
| KR4651 | 31/05/2022 | 18g = 140 delivered doses | 13/05/2021 |
| KV4301 | 31/07/2022 | 18g = 140 delivered doses | 25/05/2021 |
| KV4299 | 31/07/2022 | 18g = 140 delivered doses | 04/06/2021 |
| KV4302 | 31/07/2022 | 18g = 140 delivered doses | 05/07/2021 |
| KY6352 | 30/09/2022 | 18g = 140 delivered doses | 13/07/2021 |
| KY6322 | 30/09/2022 | 18g = 140 delivered doses | 31/08/2021 |
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.
View full alert here
Further Information
For more information, medical information queries or stock control queries, please contact:
Nigel Kelly
013555 98155
