Public Alert No. 19/2023 – Alert on Substandard (contaminated) syrup medicines identified in WHO Region of the Western Pacific
June 13, 2023,
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers that a batch of substandard (contaminated) GUAIFENESIN SYRUP TG SYRUP has been identified in the Marshall Islands and Federated States of Micronesia, and reported to WHO on 6 April 2023.
Samples of the GUAIFENESIN SYRUP TG SYRUP from the Marshall Islands were analyzed by quality control laboratories of the Therapeutic Goods Administration (TGA) of Australia. The analysis found that the product contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
The stated manufacturer of the affected product is QP PHARMACHEM LTD (Punjab, India). The stated marketer of the product is TRILLIUM PHARMA (Haryana, India). To date, neither the stated manufacturer nor the marketer have provided guarantees to WHO on the safety and quality of these products.
Guaifenesin is an expectorant used to relieve chest congestion and the symptoms of cough. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier.
Risks
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
The contaminated Guaifenesin syrup is unsafe and its use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, 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 | GUAIFENESIN SYRUP TG SYRUP |
| Stated manufacturer | QP PHARMACHEM LTD, (Punjab, India) |
| Stated marketer | TRILLIUM PHARMA (Haryana, India) |
| Batch | SL-429 |
| Expiry date | 10/2023 |
| Identified in | Marshall Islands, Micronesia (Federated States of) |
Available Photos
NAFDAC implores manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol, and/or glycerin /glycerol, to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.
Please note that the product is not in NAFDAC database. However, importers, 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 the substandard (contaminated) syrups. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public in possession of the above-mentioned product are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
If you have these substandard products, please DO NOT use them. If you, or someone you know, have used these products, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and patients are advised to report any suspicion of sale and use 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