Class 3 Medicines Recall: Easyhaler Salbutamol Sulfate 100 micrograms per actuation/200 micrograms per actuation inhalation powder, EL (21)A/06
Orion Corporation T/A Orion Pharma (UK) Ltd are recalling specific batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored.
PL Number(s)
PL 27925/0002, PL 27925/0003
MDR Number
MDR 198-02/21
Company Name
Orion Corporation T/A Orion Pharma (UK) Ltd
Product description
Easyhaler Salbutamol Sulfate 100 micrograms per actuation inhalation powder PL 27925/0002
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 2009598 | 04/2023 | 200 actuations | 15.09.2020 |
Easyhaler Salbutamol Sulfate 200 micrograms per actuation inhalation powder PL 27925/0003
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 2016511 | 04/2023 | 200 actuations | 28.09.2020 |
Active Pharmaceutical Ingredients: Salbutamol
Brief description of the problem
Orion Corporation T/A Orion Pharma (UK) Ltd are recalling the above batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored. There is a risk that the defect possibly presents as a hole in the bulk chamber resulting in the minor loss of inhalation powder. The manufacturer has confirmed that the devices will continue to function correctly with no impact on patient safety.
Advice for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Further Information
For more information or medical information queries, please contact 01635 520300 or UK.MedicalInformation@orionpharma.com
Recipients of this Medicines Recall 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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