Recall Alert
| DRUG PRODUCT DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI. |
| 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 | Central Drugs Laboratory Karachi informed that the samples of below mentioned drug product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch | Manufacturers | Remarks |
| 1. | Santochlor ophthalmic Solution Chloramphenicol 5mg/ml (Reg # 021605) | D-330 | M/s Sante (Pvt) Ltd. A/97 S.I.T.E Super Highway Karachi. (DML # 000702) | The sample has been declared “substandard” on the basis of assay test. |
| 2. | Ciprozat Tablet Ciprofloxacin 500mg/ per tablet (Reg # 031221) | 2421 | M/s Hizat Pharmaceutical Industry. 170 Industrial Estate Jamrud Road Peshawar. (DML # 000315) | The sample has been declared “substandard” on the basis of dissolution test. |
| Risk Statement: | The above-mentioned batches of Santochlor Ophthalmic Solution (Chloramphenicol 5mg/ml) and Ciprozat Tablet (Ciprofloxacin 500mg) have been declared Substandard based on failure of assay and dissolution tests respectively. Substandard ophthalmic chloramphenicol may result in inadequate treatment of bacterial eye infections, leading to prolonged infection, worsening inflammation, or potential complications affecting vision. Substandard ciprofloxacin tablets may cause reduced therapeutic response in bacterial infections, increasing the risk of treatment failure, antimicrobial resistance, and disease progression. The most likely affected population includes patients suffering from eye infections and individuals being treated for bacterial infections, particularly those requiring timely and effective antibiotic therapy. Healthcare professionals are advised to discontinue use of the affected batches and ensure availability of quality-assured alternatives. |
| 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. |