RECALL ALERT – DRUG PRODUCTS (CLASS – I).

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/09-25-79
Action Date	25 September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection. Lignozin-A 2mL Each ml ampoule contains: Lignocaine HCI B.P…….. 20mg Adrenaline B.P………….1:80,000	LG-001	M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)	“Misbranded” as per Section 3(s)(iv) of The Drugs Act 1976 and “Sub-Standard” on the basis of Physical Test i.e Physical Description Test (Visible Particles), pH Test & Assay of Adrenaline.
2.	Satamin Injection Each ampoule contains: (Mecobalamin J.P) 500ug	MC24-030	M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734).	‘Adulterated’ as per Section_3 (a) (v) of The Drugs Act 1976.

Risk Statement:	The defects identified in the sampled injections pose serious risks to patient safety and therapeutic effectiveness. Injection Lignozin-A 2 mL (Batch LG-001) manufactured by M/s Trigon Pharmaceuticals (Pvt.) Ltd. has been declared Misbranded under Section 3(s)(iv) of the Drugs Act, 1976, and Substandard on the basis of physical description (visible particles), pH, and assay of adrenaline, raising concerns of compromised sterility, safety, and efficacy. Similarly, Satamin Injection (Batch MC24-030) manufactured by M/s Saturn Pharmaceuticals (Pvt.) Ltd. has been declared Adulterated under Section 3(a)(v) of the Drugs Act, 1976, which represents a severe violation of product quality and purity standards. The circulation and use of these defective products may lead to therapeutic failure, unpredictable adverse reactions, and potential harm to patients, warranting urgent regulatory and recall action.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products 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 Professionals	DRAP 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.