The National Agency for Food and Drugs Administration and Control (NAFDAC) has announced the international safety recall of a batch of Growlyn Drops 50ml after lab tests showed the drug contains ethylene glycol and diethylene glycol levels that exceed the required amount.
NAFDAC echoed the United Arab Emirates Ministry of Health and Prevention (MOHAP)’s safety recall in the first week of November.
Diethylene glycol is a chemical substance used in manufacturing as a solvent. It becomes a poisonous contaminant when it exceeds defined toxic doses.
Growlyn Drops 50ml for babies is manufactured by Aeon Formulations Pvt. Limited in India with batch number ADGR 2201. The affected products were manufactured as far back as March 2022.
“Laboratory analysis conducted on the product by MOHAP Quality Control Laboratory showed that Ethylene Glycol (EG) and Diethylene Glycol (DEG) exceeded the required amount,” NAFDAC’s statement read in part.
“Growlyn Drops is a dietary supplement that helps to boost immunity and promote healthy growth and development in babies.
“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.
“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.”
Checking with UAE’s MOHAP website but found nothing on Growlyn Drops safety advisory.
MOHAP’s social media had no recent news on a Growlyn Drops safety recall at press time.