Rapid Alert
| DRAP Alert No | No II/S/08-24-29 |
| Action Date | 22nd August 2024 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control Administrations 2. Therapeutic Goods Manufacturers |
| Problem Statement | Dow Chemical’s Singapore and the Incidents and Substandard/Falsified Medical Products (ISF) Regulation and Safety Unit, World Health Organization have informed DRAP that some miscreants are supplying falsified batches of Propylene Glycol with counterfeit Dow Chemical labelling in the supply chain market in Pakistan. The quality and safety of this material cannot be assured, and it should not be used in the manufacture of medical products. Details of identified falsified batches are as under:_ |
| Material | Batch/Lot No. | Manufacturer (as stated on the label) | Mfg. Date | Exp. Date |
| Propylene Glycol USP/EP | F9600L7PPA4 | Dow Europe GmbH | 18-10-2023 | 18-10-2025 |
| Propylene Glycol US/EP | F8900L8PPD6 | Dow Europe GmbH | Feb-2023 | Feb-2025 |
| USP Propylene | SS8900B3PPD5 | The Dow Chemical Company | 18/May/2023 | -Nil- |
| Risk Statement: | Diethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences. |
| Action Initiated: – | The Regulatory Field Force has taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market. |
| Advice for Therapeutic Goods Manufacturers | Manufacturers of therapeutic goods are required to follow these instructions: 1. Recall Products: If any batch of finished product has been manufactured using the same batch of the propylene glycol that has been identified as contaminated, the retained sample should be immediately analysed and these finished products should be recalled from local and export markets if found contaminated. 2 Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG. 3. Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination. 4. Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products. 5. Follow Guidelines: Adhere to the pharmacopeial monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products. Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of DEG/EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | Consumers should stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |