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
| 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
013555 98155
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.
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