The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public that the United Arab Emirate Ministry of Health and Prevention (MOHAP) in Abu Dhabi issued a safety recall on Growlyn Drops 50ml manufactured by Aeon Formulations Pvt. Ltd., India.
Laboratory analysis conducted on the product by MOHAP Quality Control Laboratory showed that Ethylene Glycol (EG) and Diethylene Glycol (DEG) exceeded the required amount.
Growlyn Drops is a dietary supplement that helps to boost immunity and promote healthy growth and development in babies.
Risk
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
Product Details
The details of the affected product are as follows:
Product Name: Growlyn Drops 50 ml
Product Manufacturer: Aeon Formulations Pvt. Ltd., India
Batch No.: ADGR 2201
Manufacturing Date: March 2022
Although the product is not in the NAFDAC database, importers, distributors, retailers, and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of substandard (contaminated) syrups. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Anyone in possession of the above-mentioned product is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office. If you have used this product on your baby, or someone you know, has used it or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
