Recall Alert
| DRUG PRODUCT DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB. |
| DRAP Alert No | No II/S/03-26-14 |
| Action Date | 11 March, 2026. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard ’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Medizole Suspension 60m1 Each 5 ml contains metronidazole….40 mg Furazolidone….25 mg (Reg # 005721) | SR260004 | M/s Medicon Pharmaceutical Industries (Pvt) Ltd. 11 Industrial Estate Hayatabad Peshawar (DML # 000215) | The sample is “Substandard” on the basis of pH test performed. |
| 2. | Sachet PURGO 4mg Each sachet contains: Montelukast Sodium eq. to Montelukast …….4mg (Reg # 076497) | 055 | M/s Hiranis Pharmaceuticals (Pvt) Ltd. Plot No. E-145 to E-149 North Western Industrial Zone Port Qasim, Karachi. | The sample is “Substandard” on the basis of impurities test. |
| 3. | Sachet G-Mont Each sachet contains: Montelukast Sodium eq. to Montelukast …….4mg (Reg # 080691) | GMT108 | M/s GT Pharma (Pvt) Ltd. 713 Sundar Industrial Estate Lahore. (DML # 000829) | The sample is “Substandard” on the basis of impurities test. |
| Risk Statement: | The above-mentioned products have been declared Substandard based on laboratory testing (pH and impurities failure). Substandard medicines may result in reduced therapeutic effectiveness, delayed recovery, or unexpected adverse reactions. Children suffering from diarrhea and gastrointestinal infections (Medizole Suspension) and pediatric patients using Montelukast sachets for asthma or allergic conditions are most likely to be affected. Treatment failure in these populations may lead to worsening of symptoms, increased risk of complications, and unnecessary escalation of therapy. |
| Action Initiated | – The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors 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 by Email at gsms∂dra.gov.pk. –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 this defective batch of the product. -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 these 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. |