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. |