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Recall Alert – Orange Auto disable Syringes 5mL (Batch # S5102402), DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

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MEDICAL DEVICE DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert NoNo I/S/09-25-82
Action Date30 September, 2025.
Target Audience– National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses.
– General Public
Problem / Issue Central Drugs Laboratory (CDL) Karachi, has declared the sample of below mentioned Medical Device as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.ManufacturersRemarks
1.Orange Auto disable Syringes 5ml
(MDMR # 000078)		S5102402M/s Silver Surgical Complex (Pvt) Ltd,
C-40, S.I.T.E II, Super Highway Industrial Area Scheem 33, Karachi.
(ELM # 0007)		Sample has been declared of ‘substandard’ quality on the basis of results for Auto disable feature.
Risk Statement:This defect poses a high risk of reuse of syringes, which may result in cross-contamination and transmission of bloodborne infections such as HIV, hepatitis B, and hepatitis C. Because the defect is not visually detectable before use, healthcare professionals and patients remain unaware of the risk. Given the widespread use of such syringes in general healthcare settings, including immunization programs and vulnerable populations, the risk is categorized as HIGH, and immediate market withdrawal and user alert are necessary to protect public health.
Action Initiated– The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches 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 ProfessionalsDRAP 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.