Year: 2026
32. Rapid Alert – SPURIOUS / FALSIFIED DANZEN DS TABLETS
Rapid Alert
| SPURIOUS / FALSIFIED DANZEN DS TABLETS |
| DRAP Alert No | No I/S/06-26-31 |
| Action Date | 02 June, 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug Testing Laboratory (DTL), Government of Punjab has reported that the sample of the following drug product has been declared SPURIOUS under Section 3(z-b)(i) & (ii) of the Drugs Act, 1976, based on the laboratory findings and confirmation received from the manufacturer. |
| S# | Product Name | Batch | Manufacturer | Remarks |
| 1 | DANZEN® DS Tablets (Serratiopeptidase 10 mg) Reg. No. 028173 | 4476 | Purportedly manufactured under license of Helix Pharma (Pvt.) Ltd., Karachi. | Declared Spurious by DTL; Serratiopeptidase not identified; Assay 0%; Manufacturer has confirmed the sample was not manufactured by Helix Pharma and has disowned the batch. |
Helix Pharma (Pvt.) Ltd. has formally communicated to the regulatory authorities that the submitted sample was not manufactured by the company. Following a comparative investigation against its reference sample.
| S.# | Parameters | Reference Sample (Danzen DS 10mg Batch No. 4476) | Manufacturer Portion / spurious (Danzen DS 10mg Batch No. 4476) |
| 01 | Color of Tablet | Color of tablet observed dark pink with smooth coating as compare to Warrantor sample. | Color of tablet observed different. |
| 02 | Color of Blister Strip | Color of blister observed Blue. | Color of blister observed different as dark blue. |
| 03 | Font size and Style of Embossed Batch number and Expiry | Font size and style of embossed batch number and expiry observed as per standard font size. | Font size and style of embossed batch number and expiry observed different as compare to reference standard sample. |
| Risk Statement | Laboratory analysis conducted by Drug Testing Laboratory, Punjab revealed that Serratiopeptidase, the declared active pharmaceutical ingredient, could not be identified in the tested sample. Assay testing demonstrated complete absence of the declared active ingredient, with results showing 0.0 mg/tablet against the labeled claim of 10 mg/tablet. Use of this counterfeit/spurious product may result in: Complete therapeutic failure. Failure to achieve the intended anti-inflammatory effect. Delay in appropriate treatment and recovery. Exposure to unknown or undeclared ingredients of uncertain quality, safety and efficacy. Potential adverse health consequences arising from the use of falsified medicines. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link. |
| Advice for Consumers | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should 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. |
31. Rapid Alert – SPURIOUS / FALSIFIED BREXIN TABLETS 20 mg
Rapid Alert
| SPURIOUS / FALSIFIED BREXIN TABLETS 20 mg |
| DRAP Alert No | No I/S/06-26-31 |
| Action Date | 02 June, 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug Testing Laboratory (DTL), Government of Punjab, has reported that under Section 3(z-b)(i) & (ii) of the Drugs Act, 1976, based on the laboratory findings and confirmation received from the Marketing Authorization Holder, the sample of the following drug product is considered a Falsified/spurious. |
| S# | Product Name | Batch | Manufacturer | Remarks |
| 1 | Brexin Tablets 20 mg (Piroxicam-β-Cyclodextrine) Reg. No. 010637 | 1207863 | Purportedly manufactured under license of Chiesi Farmaceutici S.p.A., Parma, Italy | Declared Spurious by DTL; Piroxicam not identified; Assay 0%; Marketing Authorization Holder has confirmed that the sample is not a genuine Chiesi product and has disowned the batch. |
M/s Chiesi Pharmaceuticals (Pvt.) Ltd., Pakistan, the authorized marketer of Brexin in Pakistan, has formally communicated to the regulatory authorities that the seized sample was neither manufactured under license of Chiesi Farmaceutici S.p.A., Italy, nor marketed or distributed through its authorized supply chain. The company has also identified multiple packaging discrepancies between the seized sample and authentic Brexin tablets and has categorically disowned the product as counterfeit/spurious.
| Brexin (Chiesi) | Brexin (Spurious/Counterfeit) |
| Unit carton is sealed with transparent tape on both closure sides | Unit carton is not sealed with tape of Chiesi specifications |
| Font (Size & Style) is specific for Chiesi | Font (Size & Style) is different |
| Variable data is printed through Inkjet printer | Variable data is pre-printed |
| Tablet color is pale yellow | Tablet color is dark yellow or pigmented at some spots |
| Aluminum foil is specific for Chiesi | Aluminum foil is shiny which is not Chiesi specifications |
| Blister color is off white | Blister color is white |
| Printing of variable data on blister is Chiesi specific | Stamping of variable data is different than Chiesi printed |
| Leaflet color is white printed on imported paper | Leaflet color is pale yellow local paper |
| Risk Statement | Laboratory analysis conducted by Drug Testing Laboratory, Punjab, revealed that the declared active pharmaceutical ingredient (Piroxicam) could not be identified in the sample. Assay results demonstrated 0.0% content of Piroxicam against the labeled claim of 20 mg per tablet, indicating complete absence of the declared active ingredient. Use of this counterfeit/spurious product may result in: Complete therapeutic failure in patients requiring anti-inflammatory and analgesic treatment. Delay in appropriate medical management due to false reliance on ineffective therapy. Potential exposure to unknown or undeclared ingredients of uncertain quality, safety, and efficacy. Increased risk of adverse health outcomes, particularly in patients suffering from painful inflammatory conditions. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link. |
| Advice for Consumers | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should 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. |
30. Recall Alert – CDL Declared Sub-standard Medical Devices
Recall Alert
| MEDICAL DEVICES DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI |
| DRAP Alert No | No I/S/06-26-30 |
| Action Date | 01 June, 2026 |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Central Drugs Laboratory (CDL), Karachi has informed that samples of the below-mentioned Auto Disable Syringes have been declared “Substandard” due to failure of the Self-Destructive Performance / Auto-Disability Test (re-use prevention feature). |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Manufacturer / Importer & Address | Batch No. | Remarks |
| 1 | Zindagi Auto Disable Syringes 3ml/cc (MDMR-000117) | Manufacturer: M/s Al-Badar Manufacturing (Pvt.) Ltd. Plot No. 193/3, Road No. 7, Industrial Estate, Gadoon Amazai, District Swabi, Khyber Pakhtunkhwa, (ELM-0029) | 3-01B-26 | Substandard |
| 2 | Zindagi Auto Disable Syringes 3ml/cc (MDMR-000117) | 3-01A-26 | Substandard | |
| 3. | Biosoft Auto Lock Safety Syringe 3cc/ml (MDIR-0002506) | Manufacturer: M/s Jiangxi Fenglin Medical Appliances Co. Ltd, Jiangxi China Importer: M/s Hashir Surgical Services Office No 16, Street 1, F-2, Phase 6, Hayatabad, Peshawar | 20250810 | Substandard |
| 4. | I.CO Safety Syringe 5ml (MDIR-0002291) | Importer: M/s Capra-Med (Pvt) Ltd First Floor 81, Broadway Commercial, Paragon City Barki Road, Lahore Manufacturer: M/s Med ELDawlaico International Company for Medical Necessities | 2510 | Substandard |
| 5. | Injekt Auto Disable Syringe 3ml (MDMR-000147) | Manufacturer: Lahore Medical Instruments (Pvt.) Ltd. Kasur | 3-018 | Substandard |
| 6. | Yashfaeen Sterile Self Destruction Safety Syringe 3ml [Auto Disable Syringe] (MDIR-0006365) | Importer: M/s Tech Zone Ground Floor, Weal House 8, Faiz Road, Old Muslim Town, Lahore. Manufacturer: M/s Shandong Caremed Medical Products Co., Ltd., (Yantai) Industrial park, Dingtao County, Heze 274100 Shandong PR China | 20250930 | Substandard |
| 7. | Yashfaeen Sterile Self Destruction Safety Syringe 5ml [Auto Disable Syringe] (MDIR-0006365) | Importer: M/s Tech Zone Ground Floor, Weal House 8, Faiz Road, Old Muslim Town, Lahore. Manufacturer: M/s Shandong Caremed Medical Products Co., Ltd., (Yantai) Industrial park, Dingtao County, Heze 274100 Shandong PR China | 20250930 | Substandard |
| Risk Statement: | Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). Reuse of such defective syringes may also result in cross-contamination, healthcare-associated infections and serious public health consequences, particularly during immunization programmes and other invasive medical procedures. |
| Action Initiated | -The field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements. –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 increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link. |
| Advice for Pharmacies/Medical stores: – | All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products. |
| Advice for Consumers | Consumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre. |
29. Recall Alert – DTL Sindh declared Substandard Auto Disable Syringes
Recall Alert
| DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES |
| DRAP Alert No | No I/S/05-26-29 |
| Action Date | 22nd May, 2026 |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratory Sindh, Karachi has informed the Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical devices have been declared “Substandard” due to failure of the Self-Destructive Performance / Auto-Disability Test (re-use prevention feature). |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Manufacturer / Importer & Address | Batch No. | Remarks |
| 1 | Medi Aqua Auto Disable Syringe 5ml (MDMR-000145) | M/s Frontier Pharmaceutical (Pvt.) Ltd., W-10, Industrial Estate, Jamrud Road, Peshawar, Pakistan | AD1C25 | Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature). |
| 2 | Zindagi Auto Disable Syringe 3ml (MDMR-000117) | M/s Al-Badar Manufacturing (Pvt.) Ltd., Plot No.193/3, Road No.7, Industrial Estate Gadoon Amazai, District Swabi, Khyber Pakhtunkhwa, Pakistan | 3-OL-25 | Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature). |
| 3 | Shifa Auto Destruct Syringe 3ml (MDIR-0002262) | Importer: M/s SY’AH Impex, 1-6/15 Sector-5, Korangi Industrial Area, Karachi. Manufacturer: M/s Changzhou Tongda Medical Appliance Co., Ltd., Sanhekou Street, Zhenglu Town, Tianning District, Changzhou, Jiangsu, China. | 20251210 | Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature). |
| 4 | Unilock Auto Disable Syringe 3ml (MDMR-000138) | M/s Unisa (Pvt.) Ltd., Main G.T. Road, Adamzai, Akora Khattak, District Nowshera, Khyber Pakhtunkhwa, Pakistan | 2506303 | Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature). |
| 5 | Shifa Auto Destruct Syringe 5ml (MDIR-0002262) | Importer: M/s SY’AH Impex, 1-6/15 Sector-5, Korangi Industrial Area, Karachi. Manufacturer: M/s Changzhou Tongda Medical Appliance Co., Ltd., Sanhekou Street, Zhenglu Town, Tianning District, Changzhou, Jiangsu, China. | 20251020 | Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature). |
| 6 | Bio Safe Auto Disable Syringe | M/s Injection Systems (Pvt.) Ltd., Plot No. 271, Main Road, Industrial Estate Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan | X25L01 | Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature). |
| Risk Statement: | Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). Reuse of such defective syringes may also result in cross-contamination, healthcare-associated infections and serious public health consequences, particularly during immunization programmes and other invasive medical procedures. |
| Action Initiated | The field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements. |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link. |
| Advice for Pharmacies/Medical stores: – | All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products. |
| Advice for Consumers | Consumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre. |
28. Recall Alert – CDL Karachi declared substandard Auto Disable Syringes.
Recall Alert
| MEDICAL DEVICES DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI |
| DRAP Alert No | No I/S/05-26-28 |
| Action Date | 22nd May, 2026 |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Central Drugs Laboratory (CDL), Karachi has informed that samples of the below-mentioned Auto Disable Syringes have been declared “Substandard” due to failure of the Self-Destructive Performance / Auto-Disability Test (re-use prevention feature). |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Manufacturer / Importer & Address | Batch No. | Remarks |
| 1 | Ultra Fine SMD Painless Syringe 3ml (MDMR-000229) | Manufacturer: M/s Sehat Medical Devices (Pvt.) Ltd., Lahore, Pakistan | 3008DA | Substandard |
| 2 | Ultra Fine SMD Painless Syringe 3ml (MDMR-000229) | Manufacturer: M/s Sehat Medical Devices (Pvt.) Ltd., Lahore, Pakistan | 3016DC | Substandard |
| 3 | Venus Auto-Disable Syringe 5ml (MDMR-000453) | Manufacturer: M/s Bioron Medics (Pvt.) Ltd., Lahore, Pakistan | 082602002 | Substandard |
| 4 | Venus Auto-Disable Syringe 3ml (MDMR-000453) | Manufacturer: M/s Bioron Medics (Pvt.) Ltd., Lahore, Pakistan | 072602002 | Substandard |
| 5 | Medi Aqua Auto Disable Syringe 3ml (MDMR-000145) | Manufacturer: M/s Frontier Pharmaceutical (Pvt.) Ltd., W-10, Industrial Estate, Jamrud Road, Peshawar, Pakistan | AD1B25 | Substandard |
| 6 | Medi Aqua Auto Disable Syringe 5ml (MDMR-000145) | Manufacturer: M/s Frontier Pharmaceutical (Pvt.) Ltd., W-10, Industrial Estate, Jamrud Road, Peshawar, Pakistan | AD1C25 | Substandard |
| 7 | Clinic Auto Disable Syringe 3ml/cc (MDMR-000115) | Manufacturer: M/s Surgi Plast Industries, Industrial Estate, Gadoon Amazai, District Swabi, Khyber Pakhtunkhwa, Pakistan | 3-01C-26 | Substandard |
| 8 | Clinic Auto Disable Syringe 3ml/cc (MDMR-000115) | Manufacturer: M/s Surgi Plast Industries, Industrial Estate, Gadoon Amazai, District Swabi, Khyber Pakhtunkhwa, Pakistan | 3-01B-26 | Substandard |
| 9 | Bio Safe Auto Disable Syringe | Manufacturer: M/s Injection Systems (Pvt.) Ltd., Plot No. 271, Main Road, Industrial Estate Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan | Y26CO1 | Substandard |
| 10 | Medline Sterile Auto-Disable Syringe with Needle (MDIR-0001535) | Importer: M/s Platinum Corporation, F-10/7/6 Near Arfeen Masjid, Barrage Colony, Sukkur, Pakistan. Manufacturer: M/s Yangzhou Medline Industry Co., Ltd.China. | 20240910 | Substandard |
| 11 | L.D Tru-Lock Auto-Disable Syringe 3ml/5ml (MDMR-000174) | Manufacturer: M/s Lasani Healthcare, Plot No. 29-A/R-1, Industrial Estate, Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan | 2604- 54TL3 | Substandard |
| Risk Statement: | Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). Reuse of such defective syringes may also result in cross-contamination, healthcare-associated infections and serious public health consequences, particularly during immunization programmes and other invasive medical procedures. |
| Action Initiated | -The field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements. –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 increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link. |
| Advice for Pharmacies/Medical stores: – | All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products. |
| Advice for Consumers | Consumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre. |