Rapid Alert
| DRAP Alert No | No I/S/09-24-32 |
| Action Date | 06th September 2024 |
| Target Audience | · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. · General Public |
| Problem / Issue | The Directorate of Drugs Control (DDC), Punjab has identified contamination with ethylene glycol and diethylene glycol in the following liquid preparations. Analysis from Drug Testing Laboratories (DTLs) has declared these products as Substandard |
Therapeutic Good(s) Affected: –
The details of the affected batches are as follows:
| S# | Product Name | Composition | Batch No. | Manufactured by |
| 01 | Cestonil Plus syrup Reg. No. 021843 | Thiamine 1.75mg, Riboflavin 2.62mg, Pyridoxine 1.54mg, Nicotinamide 10.50mg | 061357 | M/s. Razzee Therapeutics, Lahore |
| 02 | Texcol DM 10mg/5ml syrup Reg. No. 025034 | Dextromethorphan | 09980 | M/s. Razzee Therapeutics, Lahore |
| 03 | Speczine 5mg/5ml Syrup Reg. No. 012597 | Promethazine | 280 287 | M/s. Spectrum Laboratories, Lahore |
| 04 | Aphylin Syrup Reg. No. 026635 | Aminophylline 32mg, Diphenhydramine 8mg, Ammonium HCl 30mg | 24B056 | M/s. Obsons Pharmaceuticals, Lahore |
| 05 | Zolint Suspension Reg. No. 016494 | Furazolidone 25mg/5ml, Metronidazole 75mg/5ml | 24003 | M/s. Libra Private Ltd., Peshawar |
| Risk Statement | Di-ethylene Glycol (DEG) and Ethylene Glycol (EG) contaminated oral 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 | -All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these defective batches of liquid products. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |