MHRA Class 3 Medicines Recall: Easyhaler Salbutamol Sulfate 100 & 200micrograms per actuation

MHRA Class 3 Medicines Recall: Easyhaler Salbutamol Sulfate 100 & 200micrograms per actuation

March 1, 2021

Class 3 Medicines recall: Easyhaler Salbutamol Sulfate 100 & 200micrograms per actuation inhalation powder (Orion Corporation T/A Orion Pharma (UK) Ltd)

Drug alert number: EL (21) A/06

Date issued: 1st March 2021

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for:

Easyhaler Salbutamol Sulfate 100 & 200micrograms per actuation inhalation powder (Orion Corporation T/A Orion Pharma (UK) Ltd) PL 27925/0002 and PL 27925/0003

Orion Corporation T/A Orion Pharma (UK) Ltd are recalling the batches below 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.

Easyhaler Salbutamol Sulfate 100micrograms 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 200micrograms per actuation inhalation powder PL 27925/0003

Batch Number Expiry Date Pack Size First Distributed
2016511 04/2023 200 actuations 28.09.2020

Advice for healthcare professionals

  • Stop supplying the batches listed above immediately.
  • Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Full drug alert can be viewed here.

Company contacts for further information

For more information or medical information queries, please contact 01635 520300 or UK.MedicalInformation@orionpharma.com 

 



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