ISLAMABAD: The Drug Regulatory Authority of Pakistan has issued recall alerts for 17 batches of auto-disable syringes manufactured and imported by multiple companies after laboratory testing found failures in critical reuse-prevention safety mechanisms designed to stop syringes from being used more than once.
The recall alerts were issued following notifications from Central Drugs Laboratory and Drug Testing Laboratory Sindh, both of which declared several syringe samples “substandard” after they failed the Self-Destructive Performance / Auto-Disability Test.
Auto-disable syringes are specifically designed to lock or disable after a single use in order to prevent reuse and reduce unsafe injection practices in healthcare settings.
Health experts warn that failures in reuse-prevention mechanisms can undermine infection-control protocols and increase public health risks associated with unsafe syringe reuse.
According to DRAP, the affected products include both locally manufactured and imported 3ml and 5ml auto-disable syringes distributed in different parts of the country.
The regulator directed provincial drug control authorities, healthcare facilities, distributors, pharmacies, and field enforcement teams to identify, remove, and prevent further distribution of the affected syringe batches from medical supply chains. Manufacturers and importers were also instructed to immediately initiate product recalls from the market.
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Among the products declared substandard by CDL Karachi were two batches of Ultra Fine SMD Painless Syringe 3ml (MDMR-000229) manufactured by M/s Sehat Medical Devices (Pvt.) Ltd., Lahore, Pakistan. The affected batch numbers are 3008DA and 3016DC.
CDL Karachi also declared Venus Auto-Disable Syringe 5ml (MDMR-000453), batch number 082602002, and Venus Auto-Disable Syringe 3ml (MDMR-000453), batch number 072602002, manufactured by M/s Bioron Medics (Pvt.) Ltd., Lahore, Pakistan, as substandard.
Two additional syringe batches manufactured by M/s Frontier Pharmaceutical (Pvt.) Ltd., W-10, Industrial Estate, Jamrud Road, Peshawar, Pakistan, were also recalled. These include Medi Aqua Auto Disable Syringe 3ml (MDMR-000145), batch number AD1B25, and Medi Aqua Auto Disable Syringe 5ml (MDMR-000145), batch number AD1C25.
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CDL Karachi further identified two batches of Clinic Auto Disable Syringe 3ml/cc (MDMR-000115) manufactured by M/s Surgi Plast Industries, Industrial Estate, Gadoon Amazai, District Swabi, Khyber Pakhtunkhwa, Pakistan. The recalled batch numbers are 3-01C-26 and 3-01B-26.
Another affected product is Bio Safe Auto Disable Syringe manufactured by M/s Injection Systems (Pvt.) Ltd., Plot No. 271, Main Road, Industrial Estate Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan. The affected batch number is Y26CO1.
CDL Karachi also declared Medline Sterile Auto-Disable Syringe with Needle (MDIR-0001535), batch number 20240910, as substandard. The product was imported by M/s Platinum Corporation, F-10/7/6 Near Arfeen Masjid, Barrage Colony, Sukkur, Pakistan, and manufactured by M/s Yangzhou Medline Industry Co., Ltd., China.
Additionally, L.D Tru-Lock Auto-Disable Syringe 3ml/5ml (MDMR-000174), manufactured by M/s Lasani Healthcare, Plot No. 29-A/R-1, Industrial Estate, Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan, was also included in the recall alert issued by CDL Karachi. No batch number was mentioned in the alert for this product.
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Separately, Drug Testing Laboratory Sindh declared six additional syringe batches substandard over the same failure in reuse-prevention testing.
These include Medi Aqua Auto Disable Syringe 5ml (MDMR-000145), batch number AD1C25, manufactured by M/s Frontier Pharmaceutical (Pvt.) Ltd., Peshawar, Pakistan.
DTL Sindh also recalled Zindagi Auto Disable Syringe 3ml (MDMR-000117), batch number 3-OL-25, manufactured by M/s Al-Badar Manufacturing (Pvt.) Ltd., Plot No.193/3, Road No.7, Industrial Estate Gadoon Amazai, District Swabi, Khyber Pakhtunkhwa, Pakistan.
Two imported products marketed under the Shifa Auto Destruct Syringe brand were also declared substandard. These include Shifa Auto Destruct Syringe 3ml (MDIR-0002262), batch number 20251210, and Shifa Auto Destruct Syringe 5ml (MDIR-0002262), batch number 20251020.
The products were imported by M/s SY’AH Impex, 1-6/15 Sector-5, Korangi Industrial Area, Karachi, and manufactured by M/s Changzhou Tongda Medical Appliance Co., Ltd., Sanhekou Street, Zhenglu Town, Tianning District, Changzhou, Jiangsu, China.
Another recalled product is Unilock Auto Disable Syringe 3ml (MDMR-000138), batch number 2506303, manufactured by M/s Unisa (Pvt.) Ltd., Main G.T. Road, Adamzai, Akora Khattak, District Nowshera, Khyber Pakhtunkhwa, Pakistan.
DTL Sindh also declared Bio Safe Auto Disable Syringe, batch number X25L01, manufactured by M/s Injection Systems (Pvt.) Ltd., Plot No. 271, Main Road, Industrial Estate Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan, as substandard.
Public health experts note that auto-disable syringes are widely used in vaccination campaigns, hospitals, clinics, and public health programs because they are intended to prevent reuse after a single injection. Failures in such safety mechanisms can compromise injection safety protocols and increase healthcare risks if devices are improperly reused.
Unsafe injection practices remain a major public health concern in many developing countries, including Pakistan, where reused syringes have historically contributed to the spread of bloodborne infections including hepatitis B, hepatitis C, and HIV.
Healthcare regulators have increasingly intensified surveillance of medical devices and disposable healthcare products amid concerns regarding manufacturing quality standards, infection control, and patient safety within healthcare systems.
DRAP instructed healthcare providers, pharmacies, distributors, and procurement authorities to immediately stop the use and distribution of the affected syringe batches and report any remaining stock to relevant provincial drug inspectors.
The regulator further directed field formations across the country to conduct market surveillance and ensure removal of the identified batches from circulation.
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