Recall Alert: Drug Products; Recall of 12 Substandard Batches from the Market

Asad Ullah Recall Alerts June 14, 2024June 14, 2024

Recall Alert

DRAP Alert No	N^oI/S/05-24-28
Action Date	14^th June 2024.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public
Problem / Issue	The Directorate of Drugs Control (DDC) Punjab vide Alert No. 137/2024 and 135/2024 has informed that the following samples of drug products have been declared as Substandard by Drug Testing Laboratories (DTL). The Details of affected product batches is tabulated below.

Therapeutic Good(s) Affected: –

S#	Product Name	Composition	Batch No.	Manufactured by	Test Results
01	Metroin 100ml infusion	Metronidazole	MT23-014	M/s. Saturn Pharmaceuticals, Lahore.	Substandard
02	Tozen-D Ophthalmic Suspension	Tobramycin and Dexamethasone	TW019	M/s. Epharm Laboratories, Karachi.	Substandard
03	Ann-Vil 50ml Injection	Pheniramine Maleate	V-44423	M/s. Venus Pharma, Lahore.	Substandard
04	Arpes 500mg Powder for Injection	Acyclovir	AR-099	M/s. MTI Medical, Lahore.	Substandard
05	Torax 60ml Syrup	Acefylline Piperazine and Diphenhydramine	24-24	M/s. Siza International, Lahore.	Unacceptable Ethylene Glycol level identified
06	Zonid 200mg/5ml syrup 120ml	Metronidazole Benzoate	Z396 Z244 Z243 Z413 Z398 Z414 Z397	M/s. Bloom Pharmaceuticals, Hattar.	Unacceptable Ethylene Glycol level identified

Action Initiated	–The manufacturers have been directed to immediately recall the defected batches of their products from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of 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, or through phone at +92 51 910 73 17, 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.