123. Recall Alert (Class-I) – Drug Products (Human) Substandard – Gligit Baltistan.

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUGS TESTING LABORATORY.

DRAP Alert No	No II/S/12-25-123
Action Date	18 December, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drugs, Water & Food Testing Laboratory, Government of Gilgit Baltistan informed that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Remarks	Manufacturers
1.	Glitric Tablets Each prolonged release tablet contains: Glyceryl Trinitrate …………… 2.6 mg (Reg. # 119607)	25H261 & 25H262	Batch # 25H261 The sample has been declared “Substandard” on the basis of Assay & Dissolution Test.   Batch # 25H262 The sample has been declared “Substandard” on the basis of Assay Test.	M/s Linta Pharmaceuticals. Plot # 03, Street S-5, National Industrial Zone, Rawat, Islamabad. (DML # 000810)
2.	Betahist Tablet Each Tablet contains: Betahistine DiHydrochloride … 16 mg (Reg. 091595)	25H249	The sample has been declared “Substandard” on the basis of Physical description. (Tablets found with softening, cracking, rough orange peel texture, easily break, and become powder when pressed with fingers).

Risk Statement:	The identified quality defects in Glyceryl Trinitrate prolonged-release tablets (Glitric 2.6 mg), including failure of assay and dissolution, and the severe physical instability observed in Betahistine tablets (Betahist 16 mg) may result in therapeutic failure and unpredictable dosing. Glyceryl Trinitrate is a critical cardiovascular medicine with a sensitive therapeutic window, and inadequate dosing may precipitate angina or serious ischemic events, particularlyinelderly patients and those with ischemic heart disease. Betahistine defects may lead to loss of efficacy in patients suffering from vertigo and balance disorders. The public most likely to be affected includes chronic cardiovascular and vestibular disorder patients, especially the elderly and comorbid populations.
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.