其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Pfizer Limited, Depo-Medrone with Lidocaine 40 mg／ml (1 ml and 2 ml vials; single vial preparations) (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Pfizer Limited has informed MHRA that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the 5 batches of Depo-Medrone with Lidocaine (methylprednisolone acetate and lidocaine hydrochloride) 40 mg/ml (1 ml and 2 ml vials; single vial presentations) (batch number: EL4771, FK6842, EK3997, FK6089, FN9557) to the United Kingdom market. For the detailed differences between the incorrect and correct PILs, please refer to the website in MHRA.
Healthcare professionals should ensure that appropriate patient counselling takes place and patients are aware of the missing information. The impacted product is within product specification and there is no issue with product quality.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-pfizer-limited-depo-medrone-with-lidocaine-40-mg-slash-ml-1-ml-and-2-ml-vials-single-vial-preparations-el-22-a-slash-18
In Hong Kong, Depo Medrol With Lidocaine Inj (HK-00437) is a pharmaceutical product registered by Pfizer Corporation Hong Kong Limited (Pfizer). The product is a prescription-only medicine. As confirmed with Pfizer, the affected batches have not been imported into Hong Kong.
Ends/Friday, Apr 22, 2022
Issued at HKT 16:00
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