Class 2 MHRA drug alert – Ventolin Accuhaler 200mcg (Glaxo Wellcome UK Ltd)

Class 2 MHRA drug alert – Ventolin Accuhaler 200mcg (Glaxo Wellcome UK Ltd)

February 21, 2018

Drug alert number: EL (18) A/03

Date issued: 21st February 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2, patient, pharmacy and wholesaler level recall, to be actioned within 48 hours, for certain batches of:

Ventolin Accuhaler 200mg inhaler pack size 1 x 60 (Glaxo Wellcome UK Ltd)

PL number: PL 10949/0252

Lot numbers: 786G and 754P

Expiry date: 05/2019

Glaxo Wellcome UK Limited is recalling the above Lots because a manufacturing issue has been identified which has resulted in a small number of units not delivering the full number of doses.

The MHRA has advised healthcare professionals to do the following:

  • quarantine any remaining stock of these Lots and return to the original supplier for credit;
  • identify patients or carers who have received Ventolin Accuhaler 200mcg since 31st August 2017;
  • contact these patients or carers to notify them of this issue and ask them to check whether their Ventolin Accuhalers have Lot numbers 786G or 754P printed on the device and packaging; and
  • if the patient or carer has any Ventolin Accuhalers 200mcg from these Lots, they should be asked to return them to their pharmacy or their dispensing practice for replacement with a different Lot number. Please provide replacement packs to patients at point of return, to ensure that affected patients are not left without a supply of their medicine.

The MHRA has also issued patient-specific information which can be viewed on the drug alert document.

To view the alert please visit the GOV.UK website.



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