其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Zamadol SR 50 mg prolonged-release hard capsules (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Mylan UK Healthcare Ltd has informed MHRA the GTIN barcode applied on 2 batches of Zamadol (tramadol hydrochloride) SR 50 mg prolonged-release hard capsules (batch number: 8L221D and 9B225A) is incorrect. The GTIN number that should have been allocated for these batches of capsules is 05060035240173, however, 05060035241477 was applied in error which scans the batches as Zamadol Melt Tablet 50 mg. All other information on the carton and label, including the EAN barcode is correct for the above batches of Zamadol SR 50 mg prolonged-release hard capsules.
There may be residual risk in cases where wholesalers and pharmacies use automated inventory system to dispense the affected batches within the pharmacy or wholesale facility. Due to concerns with continuity of supply these batches are not being recalled at this time.
Healthcare professionals are advised that the GTIN barcode should not be used for any dispensing activities for the affected batches listed above.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-zamadol-sr-50-mg-prolonged-release-hard-capsules-pl-46302-0149-el-20-a-18
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Mar 26, 2020
Issued at HKT 17:00
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