Recall Alert: Drug Products; Recall of 11 Substandard Batches from the Market

Asad Ullah Recall Alerts September 6, 2024September 8, 2024

Recall Alert

DRAP Alert No	N^oI/S/09-24-30
Action Date	06^th September 2024.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	The Directorate of Drugs Control (DDC) in Punjab and the Quality Control Board in Baluchistan have identified the following substandard batches of pharmaceutical products based on analyzing their samples from Drug Testing Laboratories, revealing out-of-specification results. The Details of affected product batches is tabulated below:-

Therapeutic Good(s) Affected: –

S#	Product Name	Active Ingredients	Batch No.	Manufactured by	Test Results
01	Zyocain gel 15g	Lidocaine HCL 2%	244 275	M/s. Pharmawise Laboratories, Lahore	Substandard
02	Metrorise injection	Metronidazole 500mg/100ml	LV 2303	M/s. Pak risen Pharmaceuticals, Hattar	Substandard
03	Safemed Injection	Metronidazole 500mg/100ml	S-825	M/s. Ahad International Pharmaceutical Ltd., DI Khan	Substandard
04	Lyosafe Infusion	Levofloxacin	L-784	M/s. Ahad International Pharmaceutical Ltd., DI Khan	Substandard
05	Enzol-WFI injection	Sterile water for injection	1240003	M/s. Enzon Pharma, Lahore	Substandard
06	Oxytofas Injection	Oxytocin	OTI-1419	M/s. Intervac (Pvt.) Ltd., Sheikhupura	Substandard &Misbranded
07	Painsa 75mg Injection	Diclofenac Sodium	PA420	M/s. Wimits Pharmaceuticals, Lahore	Substandard
08	Midoven Injection	Furosemide	H-21924	M/s. Venus Pharma, Lahore	Adulterated
09	Mencobal Injection	Mecobalamin	083 084	M/s. Treat Pharmaceutical Industry, Lahore	Adulterated

Action Initiated	–The manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock 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, by phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance 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 products 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.