Recall

100. Recall Alert – Veterinary Drug Products Declared Substandard.

Salateen Philip Product Recalls, Recall Alerts, Safety Info October 24, 2025October 24, 2025Recall

Recall Alert

Download

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG LABORATORIES, KARACHI.

DRAP Alert No	No I/S/10-25-100
Action Date	24 October, 2025.
Target Audience	·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments. ·         Healthcare Professionals-Veterinarians ·         Farmers/consumers
Problem / Issue	Drugs Testing Laboratories from Provinces informed that the sample of below mentioned Veterinary products have been declared as ‘Substandard / Misbranded’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1.	Injection Ivotek 100ml Each ml contains: Ivermectin……….10mg (Reg. # 016284)	VM 957	M/s Star Laboratories (Pvt.) Ltd. (Animal Health Care Division) 23 Km Multan Road Lahore. (DML # 000130)	The sample is Sub-Standard with regards to Assay and Test for related substances.
2.	Injection Ivergen 10ml Each ml contains: Ivermectin………10 mg (Reg. # 023432)	607.IV	M/s Symans Pharmaceuticals (Pvt) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323)	The sample is Sub-Standard with regards to Assay and Test for related substances.
3.	Rasomycin-5 Injection 100 ml Each ml contains: Oxytetracycline HCl …. 50 mg (Reg. # 003791)	VM406	M/s Star Laboratories (Pvt.) Ltd. (Animal Health Care Division) 23 Km Multan Road Lahore. (DML # 000130)	The sample is Misbranded with regards to labelling as defined under Section 3(s)(iv) of the Drugs Act,1976 and Substandard on the basis of Bacterial Endotoxin Test.

Risk Statement:	Farmers, livestock owners, and veterinarians using these products for treatment of cattle, sheep, goats, and other farm animals are the groups most likely to be affected. The use of such defective medicines can result in loss of animal productivity, therapeutic failure, or potential residues in milk and meat, thereby posing economic and food-safety concerns for the public.
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 Veterinarian	This alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice.
Advice for Farmers and Livestock Owners	Farmers, livestock owners, and animal handlers are advised not to use the above-mentioned batches of Injection Ivotek (Batch No. VM 957), Injection Ivergen (Batch No. 607.IV), and Rasomycin-5 Injection (Batch No. VM406). Discontinue use immediately if already in possession of these products and isolate any remaining stock. If the product has already been administered, observe animals closely for signs of fever, swelling at the injection site, weakness, or lack of therapeutic response, and consult a qualified veterinarian if any abnormal signs occur. Only purchase and use registered veterinary medicines obtained through licensed distributors or veterinary outlets. Return any suspected or recalled stock to the supplier and report details to the nearest Provincial Drug Control Office or the Drug Regulatory Authority of Pakistan (DRAP) for appropriate action.

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

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

Recall Alert

Download

DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert No	No II/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.

97- RECALL ALERT – VETERINARY DRUG PRODUCT DECLARED MISBRANDED

Ahsan Hafiz Recall Alerts October 22, 2025October 22, 2025Recall

Recall Alert

Download

VETERINARY DRUG PRODUCTS DECLARED MISBRANDED BY CENTRAL DRUGS LABORATORY, KARACHI.

DRAP Alert No	No III/S/10-25-97
Action Date	22 October, 2025.
Target Audience	·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments. ·         Healthcare Professionals-Veterinarians ·         Farmers/consumers
Problem / Issue	Central Drugs Laboratory informed that the sample of below mentioned Veterinary product has been declared as ‘Misbranded’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1.	LISO-10 Powder Each gm Contains: – Lysozyme…….22% Vitamin E 50 SD…….0.5% (Reg. # 049566)	IO E004	M/s Mallard Pharmaceuticals (Pvt) Ltd. 23-KM Lahore Road Qadirpur, Multan. (DML # 000622)	The sample has been declared ‘Misbranded’ under Section 3(s)(i) of the Drugs Act, 1976. as the Batch Number, Date of Manufacturing, Date of Expiry, and Retail Pricewerenot printed or written in indelible ink in a conspicuous manner on both the outer carton and the innermost sachet.

Risk Statement:	Use of a misbranded batch undermines the ability of healthcare professionals and consumers to verify product authenticity and shelf-life, posing potential risks of administering expired or improperly stored formulations. Veterinary practitioners, distributors, and retailers are therefore advised to immediately stop distribution, sale, or use of the affected batch, segregate existing stock, and verify labeling conformity before dispensing or prescribing.
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 Veterinarian	This alert applies strictly to the specific batch listed above and does not apply to other batches of the same product. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batch under any circumstances.
Advice for Farmers and Livestock Owners	Farmers and livestock owners are advised not to use LISO-10 Powder (Batch No. IO E004) that lacks proper labeling of batch number, manufacturing and expiry dates, or retail price, as such products cannot be verified for their authenticity, quality, or safety. Using an untraceable or expired product may reduce its effectiveness in protecting animal health and may even cause adverse reactions or treatment failure. Always ensure that veterinary medicines are purchased only from licensed veterinary stores or authorized distributors, and that each pack clearly displays the batch number, expiry date, and manufacturer details in permanent ink. If any pack is found without proper labeling, stop its use immediately, retain the sample, and report the issue to the nearest Drug Control Authority or veterinary officer for regulatory follow-up and replacement through authorized channels.

95. Recall Alert – Veterinary Drug Product declared Substandard.

Ahsan Hafiz Recall Alerts October 16, 2025October 16, 2025Recall

Recall Alert

Download

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/10-25-95
Action Date	16th October, 2025.
Target Audience	·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments. ·         Healthcare Professionals-Veterinarians ·         Farmers/consumers
Problem / Issue	Drug Testing Laboratory from Province informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned Veterinary product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1.	Oxytocin Injection 50ml Oxytocin Synthetic 10-IU/mL (Reg. # 019928)	V8-5	M/s ISIS Pharmaceutical & Chemical Works.  25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)	The sample is declared “sub-standard” on the basis of Sterility testing.

Risk Statement:	The use of Oxytocin Injection 50 ml (Batch No. V8-5) declared sub-standard on the basis of sterility testing, poses a significant risk to livestock health and animal productivity. As Oxytocin is commonly administered to dairy animals such as cows and buffaloes to induce milk let-down and facilitate parturition, use of a non-sterile injection may lead to severe local infections, fever, abscesses, or systemic septicemia in treated animals. This can result in economic losses to farmers and potential contamination of milk supply. All veterinarians, livestock owners, and distributors are therefore advised to immediately discontinue the use and sale of the affected batch and ensure that only quality-assured and sterile veterinary injectable preparations are procured from licensed sources.
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 Veterinarian	This alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice.
Advice for Farmers and Livestock Owners	Farmers, dairy owners, and animal keepers are strictly advised not to use these identified batches for their cattle or other livestock, as they may cause serious illness, infection, treatment failure, or even death in animals. If any of these batches have already been given, animals should be observed carefully for unusual symptoms such as fever, weakness, swelling at the injection site, or lack of recovery, and immediate veterinary assistance should be sought. Farmers are further advised to return such products to their supplier and use only safe, registered, and quality-assured veterinary medicines and vaccines to protect the health of their animals and avoid financial losses.

94. Recall Alert (Class-II) – Substandard Drug Products.

Ahsan Hafiz Recall Alerts October 16, 2025October 16, 2025Recall

Recall Alert

Download

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No II/S/10-25-94
Action Date	16th October, 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 sample of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Kanabax Cream 15gm Each Gram contains: Dexamethasone ………… 1mg Neomycin sulphate ……… 3.5mg	KNX-272	M/s Baxter Pharmaceuticals. A-1/A Scheme No. 33 Phase-I S.I.T.E. Super Highway Karachi. (DML # 000700)	The sample is declared as “misbranded” with regards Labelling as per Section 3(s)(iv), ‘adulterated’ with regards to Section 3(a)(iv) of the Drugs Act,1976 & ‘substandard’ on the basis of Assay of Dexamethasone Phosphate.
2.	Zysic Tablet 10 mg Each film coated tablet contains: Cetirizine HCI (USP) … 10mg	727	M/s Jinnah Pharmaceuticals (Pvt) Ltd. 13-Km Lahore Road Multan. (DML # 000578)	‘Sub-Standard’ with regards to Impurities Test.

Risk Statement:	Use of Kanabax Cream (Batch No. KNX-272), declared misbranded, adulterated, and substandard, may lead to ineffective treatment, worsening of skin infections, or antimicrobial resistance, particularly in children and patients with chronic skin conditions. Similarly, Zysic Tablet 10 mg (Batch No. 727), found substandard due to impurities, may cause reduced efficacy or mild adverse effects in allergic or asthmatic individuals. Consumers are advised to avoid these batches and seek medical advice if already used.
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.

93. Recall Alert- Syrup Synadin 60ml (Batch # L24K110) -Substandard

Ahsan Hafiz Recall Alerts October 16, 2025October 16, 2025Recall

Recall Alert

Download

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/10-25-93
Action Date	16th October, 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 sample of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Syrup Synadin 60ml Loratadine: 5mg/5ml	L24K110	M/s Synchro Pharmaceuticals.  77-Industrial Estate Kot Lakhpat Lahore. (DML # 000575)	The sample is declared as “sub-standard” on the basis of Physical Description Test, Assay Test & it contains the impurity Ethylene Glycol above the permissible limit.

Risk Statement:	Use of Synadin Syrup (Batch No. L24K110), declared substandard due to assay failure and presence of ethylene glycol impurity above permissible limits, poses a potential toxic risk, especially for children who are the primary users of antihistamine syrups. Consumers and healthcare providers are advised to immediately stop use of these batches and report any adverse events to DRAP or concerned authorities.
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.

Recall Alert – Tablet Cloferd 50 mg (Batch # 6926) declared Substandard.

Ahsan Hafiz Recall Alerts October 15, 2025October 15, 2025Recall

Recall Alert

Download

DRUG PRODUCT DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No II/S/10-25-90
Action Date	15th October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Provincial Health Department 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.	Tablet Cloferd 50 mg Each film coated tablet contains: Clomiphene Citrate .. 50mg (Reg. # 066676)	6926	M/s Medizan Laboratories (Pvt) Ltd. Plot No 313 Industrial Triangle Kahuta Road Islamabad. (DML # 000572)	The Sample is declared as “Sub-Standard” on the basis of Dissolution Test.

Risk Statement:	Clomiphene Citrate is indicated for the treatment of female infertility and ovulatory disorders. Use of a substandard product with inadequate dissolution may lead to reduced therapeutic efficacy, resulting in failure of ovulation induction, delayed conception, or treatment frustration in women of reproductive age undergoing fertility management. Timely identification and withdrawal of the affected batch are essential to prevent therapeutic failure and ensure patient safety.
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.

Recall Alert – Adulterated Tablet Virtec 10 mg (Batch # FK-24-007)

Ahsan Hafiz Recall Alerts October 15, 2025October 15, 2025Recall

Recall Alert

Download

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/10-25-89
Action Date	15th October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Provincial Health Department 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.	Тablet Virtec Each film coated tablet contains: Cetirizine Dihyrochloride 10 mg (Reg # 021870)	FK-24-007	M/s Don Valley Pharmaceuticals (Pvt) Ltd. 31-Km Ferozepur Road Lahore. (DML # 000395)	Sample is “Adulterated” as defined under clause (iv) of sub-section (a) of section 3 of The Drugs Act, 1976 as it contains “Paracetamol” as an ingredient a substance other than the prescribed substance i.e., Cetirizine Hydrochloride.

Risk Statement:	The presence of an undeclared pharmacologically active substance poses a serious risk to patient safety, as it may lead to unintended therapeutic effects, drug interactions, or dosing errors, particularly in patients concurrently taking Paracetamol-containing preparations or with hepatic impairment. This adulteration compromises the safety, efficacy, and quality of the product and indicates a critical lapse in manufacturing and quality assurance systems at the firm.
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.

Recall Alert – Drug Products declared substandard

Ahsan Hafiz Recall Alerts October 9, 2025October 9, 2025Recall

Recall Alert

Download

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/10-25-86
Action Date	09th October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Provincial Health Departments 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.	Tablet Rolekast 10mg   Each film coated tablet contains: Montelukast (as Sodium)…10 mg	1397	M/s Roryan Pharmaceutical industries (Pvt) Ltd. 85-B Hayatabad Industrial Estate Peshawar.  (DML # 000566)	The sample is declared as “Sub-Standard” on the basis of Dissolution Test and impurities test.
2.	AME-CLOP Injection Each 2mL contains: Metoclopramide HCL….10mg	MC-126	M/s Ameer Pharma (Pvt) Ltd. 23-Km Sheikhupura Road, Lahore. (DML # 000604)	sample is ‘Sub-Standard’ on the basis “Particulate contamination: visible particles” as per BP.
3.	Infusion DORCIP Each ml contains: Ciprofloxacin (as Lactate)….2mg	DC-120	M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)	The Sample is declared as “Sub-Standard” on the basis of Visible Particulates, pH Test, Sterility Test and Bacterial Endotoxin Test (BEТ).

Risk Statement:	Tablet Rolekast 10 mg (Batch 1397), used for asthma and allergic rhinitis in children and adults, has failed dissolution and impurity tests. AME-CLOP Injection (Batch MC-126), used for severe nausea, vomiting and gastrointestinal disorders in patients including pregnant women, surgical and chemotherapy cases, contains visible particles posing risk of embolism and infection and DORCIP Infusion (Batch DC-120), used in serious infections among adults and  critically ill patients, failed sterility, endotoxin and pH tests, risking sepsis and life-threatening reactions. Use of these defective medicines can cause ineffective treatment, adverse reactions, and serious safety hazards. Healthcare providers and distributors must immediately stop use and sale, quarantine affected stock, and return it to the supplier, while patients should discontinue these batches and seek medical advice if exposed.
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.

Recall Alert – Veterinary Drug Products (Substandard)

Ahsan Hafiz Recall Alerts October 9, 2025October 9, 2025Recall

Recall Alert

Download

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/10-25-84
Action Date	09th October, 2025.
Target Audience	·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments. ·         Healthcare Professionals-Veterinarians ·         Farmers/consumers
Problem / Issue	Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned Veterinary products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1	Injection Micrise-2% 50ml Ivermectin: 20 mg/ml	MR-075	M/s Biorise Pharmaceuticals. 19-Km, Lahore Road, Multan. (DML # 000934)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test.
2.	Injection Ivozon 2% 10 ml Ivermectin: 20 mg/ml	AP/INJ-G/25-83	M/s. Amazon Pharmaceutical (Pvt) Ltd.  Plot No. 10/A & 29/B, Small Industrial Estate, Bhimber, AJK (DML # 000975)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
3.	Injection IVERMEC 1% 50ml Ivermectin: 10 mg/ml	GI – 25E 140	M/s Grand Pharma (Pvt) Ltd. Plot No. 5-A Street No. N-5 National Industrial Zone Rawat (DML # 000680)	The sample is declared as “Sub-Standard” on the basis of Chromatographic Purity Test.
4.	Injection Selmec 50 ml Ivermectin: 20 mg/ml	SN-116	M/s Selmore Pharmaceuticals (Pvt) Ltd. 36 Km Off. Multan Road Lahore. (DML # 000507)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
5.	Injection Ivomek 2% 10 ml Ivermectin: 20 mg/ml	NI-807	M/s Nawal Pharmaceuticals. Plot No. 11-A Punjab Small Industrial Estate Taxila. (DML # 000735)	The sample is declared as ‘Misbranded’ as per section 3(s)(vi) of the Drugs Act 1976 & 3(g)(i) of the Drugs (Labelling and Packing) Rules 1986, and “Substandard” on the basis of Assay Test and Chromatographic Purity Test.
6.	Injection Ivergen 50ml Ivermectin: 10 mg/ml	594.IV	M/s Symans Pharmaceuticals (Pvt) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances
7.	Injection Fosphovetz Each ml contains: Butaphosphan (MS)……100mg Cyanocobalamine (B.P)..50mcg Taurine (USP)……………37.3mg Nicotinamide (B.P) ……….23mg DL-Methionine (B.P) ….18.7mg	24119013	M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)	The Sample is declared as “Sub-Standard” on the basis of Assay of Cyanocobalamine and Bacterial Endotoxin Test (BET).
8.	Oxyvetz 5% 100ml Injection   Each ml contains: Oxytetracycline HCI BP….50mg	25157083	M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)	Sample is ‘Sub-standard’ with regards to Bacterial Endotoxins Test and Misbranded with regards to Labelling (as per Section 3 (s) (iv) of The Drugs Act 1976).

Risk Statement:	Laboratory testing identified serious quality defects including assay failure, excessive impurities/related substances, misbranding of label information, and failure of bacterial endotoxin and sterility-related tests. These medicines are widely used for livestock and food-producing animals (e.g., cattle, sheep, goats) for parasitic control, metabolic support, and infection treatment. Their use can lead to ineffective therapy, toxic reactions, contamination risk, and unsafe drug residues in milk and meat, posing both animal health and public health hazards. classified as high-risk veterinary medicines requiring immediate regulatory attention.
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 Veterinarian	This alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice.
Advice for Farmers and Livestock Owners	Farmers, dairy owners, and animal keepers are strictly advised not to use these identified batches for their cattle or other livestock, as they may cause serious illness, infection, treatment failure, or even death in animals. If any of these batches have already been given, animals should be observed carefully for unusual symptoms such as fever, weakness, swelling at the injection site, or lack of recovery, and immediate veterinary assistance should be sought. Farmers are further advised to return such products to their supplier and use only safe, registered, and quality-assured veterinary medicines and vaccines to protect the health of their animals and avoid financial losses.

• ← Previous
• Next →