MHRA Class 3 Medicines Recall: Trimbow 87/5/9 mcg pressurised inhalation solution (Chiesi Ltd)

Drug alert number: EL (23)A/36

Date issued: 20 September 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 medicines recall for: Trimbow 87/5/9 mcg pressurised inhalation solution PLGB 08829/0193

SNOMED Code: 34681611000001100

Batch Number Expiry Date Pack Size First Distributed
1165031 18/09/2024 1 container with 120
actuations
19/01/2023
1150215 25/12/2023 1 container with 120
actuations
27/04/2022

Active Pharmaceutical Ingredient: 87 micrograms beclometasone dipropionate, 5 micrograms formoterol fumarate dihydrate and 9 micrograms glycopyrronium.

Brief description of the problem

Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. As a precautionary measure, Chiesi Ltd is recalling the above batches at pharmacy and wholesale level, due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stability testing.

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.

Full drug alert can be viewed here.

Advice for patients and carers

No further action is required by patients, these batches are being recalled at the pharmacy and wholesale level as a precautionary measure. Chiesi Ltd has investigated the issue and its medical assessment has shown that the impacted batches remain beneficial to patients. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact medinfo.uk@chiesi.com or telephone 0161 488 5555.

For stock control enquiries please contact customerservices.uk@chiesi.com or telephone 0161 488 5521.

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