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42. Recall Alert: SUBSTANDARD & MISBRANDED CLINIC DISPOSABLE SYRINGES 20ML BY M/S SURGI PLAST, GADOON AMAZAI, KPK

Farooq Aslam Recall Alerts

Recall Alert

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MEDICAL DEVICES (SYRINGES) DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES MANUFACTURED BY M/S SURGI PLAST, GADOON AMAZAI, KPK
DRAP Alert NoNo I/S/10-26-42
Action Date08 June, 2026
Target Audience–
– National Regulatory Field Force
– Healthcare Professional – Physician, Pharmacist, and Nurses at hospitals
– General Public
Problem / Issue Drug Testing Laboratory, Lahore has informed the Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical devices (Syringes) have been declared “Substandard” on the basis of Sterility Testing and Misbranded on the basis of labelling as two needle gauges are mentioned on label.
Sr. No.Product NameName of Manufacturer/ImporterBatch NumberRemarks
1CLINIC Disposable Syringes 20mLM/s SURGI PLAST Plot # 78, Road no. L-4, Industrial Estate Gadoon Amazai, KPK.
(ELM-0030)		20-01G-25The sample is SUBSTANDARD on the basis of Sterility test and MISBRANDED on the basis of labelling as two needle gauges are mentioned on label.

Therapeutic Goods (s) Affected: –

Risk Statement:The syringes may pose a risk of infection or other harm because they failed sterility testing. The label also lists two different gauges, which may lead to selection or use of the wrong syringe size. The use of a non-sterile syringe could introduce microorganisms into the patient, potentially causing local or systemic infection. The conflicting gauge information may also result in incorrect device selection, affecting the intended procedure or medication delivery.
Action InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.