其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Benylin Chesty Coughs Original and Benylin Chesty Coughs Non-Drowsy (English Only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that McNeil Products Limited has identified an error relating to the stated alcohol content for batches of Benylin Chesty Coughs Original and Benylin Chesty Coughs Non-Drowsy whereby the product labels understate the ethanol values. The products comply with the defined specifications, including ethanol content and, other than the incorrect ethanol content, all other label information is correct. However, the amount of ethanol contained within the products is low and hence the related on-pack safety warning, which reads “The small amount of alcohol in this medicine will not have any noticeable effects.”, is correct.
The affected products are:
- Benylin Chesty Coughs Original (diphenhydramine hydrochloride, levomenthol) (batch number: V3879R, V3880R, V4017R, V4011R, V4016R)
- Benylin Chesty Coughs Non-drowsy (guaifenesin, levomenthol) (batch number: V3366R, V3367R, V3371R, V3260R, V3621R, V3993R)
The impacted products are within specification and there is no issue with product quality. Despite the label error understating the ethanol content, the related label warning is correct. Therefore, the affected batches are not being recalled.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-benylin-chesty-coughs-original-p-and-benylin-chesty-coughs-non-drowsy-gsl-el-21-a-slash-39
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Dec 22, 2021
Issued at HKT 15:00
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