The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying drug manufacturers and the public that the World Health Organization (WHO) has issued an alert warning drug manufacturers of five contaminated batches of propylene glycol (an ingredient used as a solvent in pediatric syrups) falsely labeled as manufactured by DOW Chemical units in Asia and Europe.
The falsified DOW USP/EP PROPYLENE GLYCOL was identified in Pakistan and detected by the Drug Regulatory Authority of Pakistan (DRAP) following an investigation into the potential contamination of oral liquid medicines.
DRAP identified suspected drums of PROPYLENE GLYCOL, and Pakistan’s Central Drugs Laboratory tested samples. The analyses revealed unacceptable levels of ethylene glycol (EG) contamination, ranging from 0.76% to 100%. International manufacturing standards say only trace amounts of EG, below 0.1%, can be considered safe.
Authentic DOW USP/EP PROPYLENE GLYCOL is a raw material (excipient) utilized in pharmaceutical and other manufacturing processes, adhering to the United States and European Pharmacopoeias (USP/EP) standards for medicinal use.
DOW has confirmed that the raw materials detailed in the DRAP Alerts, and identified in this WHO Alert are falsified and were not manufactured or supplied by DOW. The quality and safety of these excipients therefore cannot be assured.
The PROPYLENE GLYCOL materials identified in this Alert are considered to have been deliberately and fraudulently mislabelled. They contain high levels of ethylene glycol, which if ingested can be toxic.
Risk
Ethylene glycol is toxic to humans when consumed and can prove fatal. Their use in medical products may result in serious injury or death, particularly in children. 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 products are as follows;
Annex 1: Products subject of WHO Medical Product Alert No. 1/2024
Product Name | DOW USP EP PROPYLENE GLYCOL | |||
Stated Manufacturer | Dow Chemical, Thailand Ltd | Dow Chemical Pacific (Singapore) Private Limited | Dow Chemical, Thailand Ltd | |
Batch Number | C815N3OR41 | C815L44R41 | C815L44R52 | C856H85R55 |
Mfg. Date | 03-23 | Not reported | Not reported | 2023 01 15 |
Expiry Date | 03-25 | Not reported | Not reported | 2025 01 15 |
Authenticity of Batch | Genuine batch number | Genuine batch number (expiry date April 2023) | Falsified batch number | Falsified batch number |
Identified in | Pakistan | |||
Product Name | PROPYLENE GLYCOL USP/EP |
Stated Manufacturer | Dow Europe, GmbH, Germany |
Batch Number | F8900L8PPD6 |
Mfg. Date | Feb 2023 |
Expiry Date | Feb 2025 |
Authenticity of Batch | Falsified batch number |
Identified in | Pakistan |
Annex 2: Available photographs – WHO Medical Product Alert No. 1/2024
NAFDAC has increased surveillance within the supply chain as these raw materials may have been distributed to other countries through informal or unregulated markets. Manufacturers of oral liquid medicines may have unknowingly purchased these contaminated raw materials, which may still be in their storage facilities.
Manufacturers of oral liquid medicines, especially syrups containing raw materials at risk of contamination with ethylene glycol (EG) and/or diethylene glycol (DEG), e.g. propylene glycol, sorbitol, and/or glycerin/glycerol, are urged to follow good manufacturing practice (GMP) requirements. They should ensure that raw materials are acquired from qualified, authorized, and approved suppliers.
Manufacturers are advised to test each batch of incoming raw materials for ethylene glycol and diethylene glycol before using them as excipients in the production of oral liquid formulations. They are also advised to inspect the current inventory on hand to determine if they have the falsified batches of the raw material, quarantine them, and immediately stop all use.
Patients who experience adverse reactions or unexpected side effects after using suspected contaminated products should also seek immediate medical attention from a healthcare professional.
Healthcare professionals and patients 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
Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of contaminated medicinal products 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!!!
