MHRA Class 4 Medicines Defect Information: Tramadol Hydrochloride 50 mg capsules & Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules (Morningside Healthcare Ltd)
MHRA Class 4 Medicines Defect Information: Tramadol Hydrochloride 50 mg capsules & Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules (Morningside Healthcare Ltd)
Drug alert number: EL (24)A/57
Date issued: 27 November 2024
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Tramadol Hydrochloride 50 mg capsules & Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules
Company name: Morningside Healthcare Limited
Product name: Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules, PL 20117/0384
SNOMED Code: 40589011000001102
| Batch Number | Expiry Date | Pack Size | First Distributed |
| MRA2303 | 05/2026 | 60 | 30/01/2024 |
Active Pharmaceutical Ingredient: tramadol hydrochloride
Product name: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 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 product’s 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 supplier’s approved process. Morningside will reimburse the wholesaler accordingly.
View full alert here.
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.
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 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.
