Class 3 Medicines Recall: Chiesi Ltd., Trimbow 87/5/9 mcg pressurised inhalation solution, EL(23)A/36
Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stability testing.
MDR number
MDR 148-09/23
Company name
Chiesi Ltd.
Product name
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 Ingredients: 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 the pharmacy and wholesale level. This is 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.
Advice for patients
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 product remains 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.
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.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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