Tuesday, 02 January 2024 12:17 GMT

Qatar Warns Against Using Baby Sleep Gripe Water After Dubai Recall


Date:

(MENAFN- Khaleej Times) Qatar has warned residents against buying and consuming Babies' Magic Tea Baby Sleep Gripe Water for undeclared alcohol levels.

The health ministry in its notice clarified that the tonic is not registered in Qatar but is available for purchase online.

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The public has been urged to immediately stop using and dispose of the product, and to seek medical advice if a child develops any symptoms following its use.

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The move comes after Dubai in October recalled some batches of the gripe water for undeclared alcohol content and a lack of valid marketing authorisation.

The Emirates Drug Establishment (EDE) had also issued a circular informing clinics and health practitioners that it is recalling batch number 25122bw of the product, "to protect the health and safety of infants". The Dubai Health Authority also disseminated the notice.

Recall in US

This product has also been recalled in the US by the Food and Drug Administration. The authority said that testing of that lot found ethanol, methanol, and isopropanol that were not declared on the product label.

Measured levels were approximately 8.3 per cent ethanol, 0.35 per cent methanol, and 0.48 per cent isopropanol. "These substances were not listed on the label," it said.

"Their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product."

According to the FDA, organic alcohols such as ethanol, methanol, and isopropanol are known to impair normal functioning of the central nervous system.

Infant ethanol exposure has been linked to long-term developmental consequences.

"Exposure to the amounts recommended on this product's packaging can induce drowsiness, incoordination, behavioural changes, nausea, vomiting, and abdominal pain", the authority said. It also warned of higher amounts of exposure that can increase risk of respiratory depression and other serious adverse health consequences.

However, it added that Pacific Health Sciences has received no reports of adverse events associated with this lot to date.

Health, safety in focus

During the past few weeks, Qatar has recalled multiple medical products, keeping in line with its health and safety measures.

In a statement on November 8, the Ministry of Public Health announced the recall of all shipments of Ferinject 50 mg/mL after tests conducted by its laboratories found it non-compliant with the company's stated chemical specifications.

Prior to that, authorities in the country recalled all batches of Isotears-Plus eye drops in the market over manufacturing defects. Isotears-Plus is a lubricating eye drop solution used for the temporary relief of burning, irritation, and discomfort caused by dry eyes or environmental exposure.

The Qatari Ministry of Health called on the members of the public who purchased the product to immediately stop using it, while stressing the commitment to patient safety and the quality of pharmaceutical products in the market.

Few days before that, another set of eye drops were recalled. The Clasgen 0.05% eye drops were found to have issues related to data integrity and sterile manufacturing processes.

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Khaleej Times

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