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
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.
DMRC Number: DMRC-33916753
Company name: Morningside Healthcare Limited
Product description: Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules, PL 20117/0384
SNOMED Code: 40589011000001102
Details of the affected batch:
| Batch Number | Expiry Date | Pack Size | First Distributed |
| MRA2303 | 05/2026 | 60 | 30/01/2024 |
Active Pharmaceutical Ingredient: tramadol hydrochloride
Product description: Tramadol Hydrochloride 50 mg capsules, PL 20117/0086
SNOMED Code: 24136911000001105
| Batch Number | Expiry Date | Pack Size | First Distributed |
| MRF2301 | 11/2027 | 30 | 06/08/2024 |
Active Pharmaceutical Ingredient: tramadol hydrochloride
Brief description of 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 product’s quality or efficacy; therefore, the affected batches are not being recalled.
Advice to 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 supplier’s approved process. Morningside will reimburse the wholesaler accordingly.
Advice to 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.
Company contacts for 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.
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