GovWire

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DMRC reference number

DMRC-33916753

Company name

Morningside Healthcare Limited

Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules, PL 20117/0384

SNOMED Code

40589011000001102

Active Pharmaceutical Ingredient: tramadol hydrochloride

Tramadol Hydrochloride 50 mg capsules, PL 20117/0086

SNOMED Code

24136911000001105

Active Pharmaceutical Ingredient: tramadol hydrochloride

Brief description of the problem

Morningside Healthcare Limited has informed the MHRA of a packaging issue identified in batch MRA2303 of Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules and batch MRF2301 of Tramadol Hydrochloride 50 mg Capsules. There have been reports of missing capsules within sealed blister strips. Each blister strip for the affected batches should contain 10 capsules. The missing capsules in the sealed blisters has occurred due to a manufacturing issue on the packaging line. The batches in the table are the only batches believed to be impacted.

Wholesalers and Healthcare professionals are advised that there is no risk to the products quality or efficacy; therefore, the affected batches are not being recalled.

Advice for healthcare professionals:

Caution should be exercised when dispensing Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules from these batches. Cartons should be opened and each blister strip inspected to confirm the presence of 10 capsules per strip before dispensing.

If missing capsules are identified, this should be reported to Morningside Healthcare Limited via the contact details below and the packs returned through your suppliers approved process. Morningside will reimburse the wholesaler accordingly.

Advice for patients:

Patients are advised that some packs may contain missing capsules. This issue affects packs with the batch numbers specified in the table. If you find missing capsules in your pack, please speak to your medicine provider immediately for further advice. The medicine itself is not affected, there are no concerns about the quality or efficacy of the capsules that are present.

If you experience any unexpected side effects or adverse reactions, these should be reported via the MHRA Yellow Card Scheme at https://yellowcard.mhra.gov.uk.

Further Information:

For medical information enquiries and reports of missing capsules or blister strips, please email medinfo@aspirepharma.co.uk or telephone 01730231148.

For all stock enquiries, please email mplcustomerservices@morningsidepharm.com or telephone 01730231148.

Recipients of this Medicines Notification 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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 4 Medicines Defect Information: Morningside Healthcare Limited, Tramadol Hydrochloride 50 mg capsules & Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules, EL(24)A/57