Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Drugsrus Limited, Clexane 10,000 IU (100mg)/1ml Syringes |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Drugsrus Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Clexane 10,000IU (100mg)/1ml Syringes (enoxaparin sodium) (batch number: ECD95D, ECI41A, FCA45G) contains a typographical error in the leaflet. The strength of the product listed in the leaflet header states “100,000 IU (100mg)/1ml” instead of “10,000 IU (100mg)/1ml”. The remainder of the packaging, including the outer packaging and information on the syringe itself details the correct strength of 10,000 IU (100mg)/1ml.
A common leaflet is used for all strengths and so this error also appears in the leaflet packaged with other strengths.
There is no risk to product quality as a result of this issue, and the affected batches are not being recalled. Healthcare professionals are advised to tell patients about the error and reassure them they have the right dose of this medicine, when dispensing subsequent batches or in discussion with patients who may raise concerns, where appropriate.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-drugsrus-limited-clexane-10000-iu-100mg-slash-1ml-syringes-el-23-a-slash-08
In Hong Kong, Clexane Inj 20mg/0.2ml (HK-38403) is a pharmaceutical product registered by Sanofi Hong Kong Limited (Sanofi). The product is a prescription-only medicine. As confirmed with Sanofi, the affected batches have not been imported into Hong Kong.
Ends/Friday, Mar 10, 2023
Issued at HKT 14:00
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