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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Class 3 Medicines Recall: Easyhaler Salbutamol Sulfate 100 micrograms per actuation inhalation powder, EL (21)A/06