Salateen Philip – Drug Regulatory Authority of Pakistan

99. Recall Alert (Class-II)- Drug Products Declared Substandard.

Salateen Philip Recall Alerts October 22, 2025October 22, 2025Recall

Recall Alert

DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert No	N^oII/S/10-25-99
Action Date	22 October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Laboratory Karachi informed that the sample of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Zolint Suspension Each 5ml contains: FURAZOLIDONE…… 25 mg Metronidazole ………. 75 mg (Reg. # 016494)	25024	M/s Libra (Pvt) Ltd. 77 Industrial Estate Hayatabad Peshawar. (DML # 000369)	The sample has been declared ‘substandard’ on the basis of assay test of Furazolidone & Metronidazole.
2.	Cytobion Capsule Each capsule contains: Mecobalamin …… 500 mcg (Reg. # 062462)	H575	M/s Hoover Pharmaceuticals (Pvt) Ltd. Plot No.16 Zain Park Industrial Area Saggian By Pass Road Lahore. (DML # 000676)	The sample has been declared ‘substandard’ on the basis of description test wherein dark red crystals not found in sample while description is white capsule containing almost white fine powder with dark red crystals.

Risk Statement:	The use of these defective medicines may result in therapeutic failure and ineffective treatment, particularly affecting vulnerable groups such as children, elderly, diabetic, and anemic patients. Substandard quality of Zolint Suspension used for infectious diarrhea may lead to prolonged illness, dehydration, and microbial resistance, while the defective Cytobion Capsule used for neuropathies and Vitamin B12 deficiency may cause delayed neurological recovery and worsening of deficiency symptoms.
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.

98-Rapid Alert- Falsified / Unregistered Aphrodisiac Drug Product

Salateen Philip Product Recalls, Recall Alerts, Safety Info October 22, 2025October 22, 2025RapidAlert

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED APHRODISIAC DRUG PRODUCTS

DRAP Alert No	N^o I/S/10-25-98
Action Date	22 October, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Central Drugs Laboratory (CDL), Karachi informed that the following drug product have been declared ‘spurious/falsified/unregistered’ upon analysis and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	JUMBO 150mg Capsules Each Capsule contains: Sildenafil Citrate ……. 150mg	JUC-05	M/s Combitic Global Caplet Pvt. Ltd. India	‘Unregistered (Falsified)’ drug product
2.	COBRA 150 Tablets Each tablet contains: Sildenafil Citrate ……. 150mg	CBT289	M/s Combitic Global Caplet Pvt. Ltd. India	‘Unregistered (Falsified)’ drug product
3.	BLACK COBRA 125 Tablets Each tablet contains: Sildenafil Citrate ……. 125mg	BOB96	M/s Combitic Global Caplet Pvt. Ltd. India	‘Unregistered (Falsified)’ drug product
4.	PENEGRA 100 Tablets Each tablet contains: Sildenafil Citrate ……. 100mg	G400016	M/s Zydus Lifesciences Limited, India.	‘Unregistered (Falsified)’ drug product
5.	BLACK COBRA 250 Tablets Each tablet contains: Sildenafil Citrate ……. 250mg	BOR-31	M/s Combitic Global, India.	‘Unregistered (Falsified)’ drug product
6.	Super CIALIS 5mg Tablets Each tablet contains: Sildenafil Citrate ……. 250mg	205-113	M/s HAB Pharmaceuticals & Research Limited, India.	‘Unregistered (Falsified)’ drug product
7.	KNIGHT RIDER DELAY SPRAY Contains Lidocaine	S-A0110	M/s Royal Herbal Ent. Co. Karachi.	‘Unregistered (Falsified)’ drug product
8.	TOKO-D3 Cream Contains Lidocaine	62051	M/s Mehran Homoeo Pharma, Mangora Swat.	‘Unregistered (Falsified)’ drug product
9.	UD Cream Contains Lidocaine	35924	M/s Mehran Homoeo Pharma, Mangora Swat.	‘Unregistered (Falsified)’ drug product

The product identification details are as under: –

Risk Statement	The above-mentioned products have been declared Unregistered and Falsified as they are not confirmed to have been manufactured, imported, or distributed through any supply chain duly authorized or licensed by the Drug Regulatory Authority of Pakistan (DRAP) or the respective Provincial Governments. The origin, composition, and quality of these products remain unverified; therefore, their safety and efficacy cannot be assured. The unregulated presence of such aphrodisiac preparations containing Sildenafil Citrate and Lidocaine poses significant public health risks, including potential cardiovascular complications, neurological adverse effects, and misuse in vulnerable populations. The continued sale or use of these products outside the legal distribution framework represents a serious threat to consumer safety and undermines regulatory control mechanisms intended to ensure the availability of genuine and quality-assured therapeutic goods.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.