其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Morningside Healthcare Limited, Tramadol Hydrochloride 50 mg capsules & Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Morningside Healthcare Limited has informed the MHRA of a packaging issue identified in Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules (batch number: MRA2303) and Tramadol Hydrochloride 50 mg Capsules (batch number: MRF2301). 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 listed above are the only batches believed to be impacted.
The products are indicated for treatment of moderate to severe pain. 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.
Caution should be exercised when dispensing from these batches. Cartons should be opened and each blister strip inspected to confirm the presence of 10 capsules per strip before dispensing.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-morningside-healthcare-limited-tramadol-hydrochloride-50-mg-capsules-and-tramadol-hydrochloride-morningside-50-mg-prolonged-release-capsules-el-24-a-slash-57
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Nov 28, 2024
Issued at HKT 15:00
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