Year: 2025
Decisions of the 104th Meeting of the Medical Device Board (MDB) held on 16-10-2025 (Part-II: Manual Applications)
105. Recall Alert – Drug Products for Human Use Declared Substandard
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES
| DRAP Alert No | No II/S/10-25-105 |
| Action Date | 30 October, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratory from Province 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. | Injection Nidagyl 100ml Metronidazole…500mg/100ml (Reg # 020601) | HM 139 | M/s Star Laboratories (Pvt) Ltd. (Human Healthcare Division), 23 Km Multan Road Lahore. (DML # 000130) | The sample is declared as “Adulterated” |
| 2. | Myteka Sachet Each Sachet contains: Montelukast (as sodium) … 4mg (Reg. # 039427) | 155321 | M/s Hilton Pharma (Pvt) Ltd. Plot No. 13 & 14 Sector 15 Korangi Industrial Area Karachi. (DML # 000136) | The sample is Sub-Standard on the basis of Impurities Test. |
| 3. | Sterile Water for Injection Water for injection 5ml | WI-132 | M/s FYNK Pharmaceuticals. 19-Km Ferozepur Road G.T. Road Kala shah Kaku Lahore. (DML # 000494) | The Sample is Sub-Standard on the basis “Visible particulate matter” as per USP. |
| Risk Statement: | The use of these defective human drug products poses potential health risks to patients. Injection Nidagyl (Batch HM 139), declared adulterated, may cause treatment failure or toxic reactions in patients receiving parenteral therapy for infections. Myteka Sachet (Batch 155321), found sub-standard due to impurities, may lead to reduced efficacy or adverse effects in pediatric and asthmatic patients commonly using Montelukast. Sterile Water for Injection (Batch WI-132), declared sub-standard due to visible particulate matter, poses a serious risk of embolism or infection in patients where sterility is critical, particularly neonates, elderly, and hospitalized patients. |
| 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. |
104. Recall Alert – Veterinary Drug Products Declared Substandard.
Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG LABORATORIES, KARACHI.
| DRAP Alert No | No I/S/10-25-104 |
| Action Date | 30 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. | Inj. Genta-Combisone 50ml Each 100 ml contains: Tylosin Tartrate………. 15 gm Gentamicin Sulphate ….6 gm Dexamethasone ……0.0265 gm Chlorpheniramine…. 0.750 gm (Reg # 046696) | GC-168 | M/s Leads Pharma (Pvt) Ltd. Plot No. 81-A Street No. 6 I-10/3 Islamabad. (DML # 000392) | The sample is Sub-Standard with regards to Sterility Test. |
| 2. | Injection Ivergen 10ml Each ml contains: Ivermectin………10 mg (Reg. # 023432) | 594.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. |
| Risk Statement: | The use of these defective veterinary injectable products may adversely affect livestock and farm animals, particularly those treated for infections or parasitic infestations. Injection Genta-Combisone poses a risk of microbial contamination due to sterility failure, which can lead to abscesses, septicemia, and reduced milk or meat yield in cattle, buffalo, goats, and other farm species. Injection Ivergen, being sub-standard in assay and related substances, may result in incomplete parasite control, therapeutic failure, and possible drug resistance in treated herds. These defects ultimately endanger the health and productivity of livestock, causing economic losses to farmers and potentially impacting the safety of animal-derived food products consumed by the general 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 and livestock owners are advised not to use the affected batches of Injection Genta-Combisone (Batch # GC-168) and Injection Ivergen (Batch # 594.IV) on their animals. The use of non-sterile or sub-standard veterinary injections can cause serious illness, swelling, infection, or treatment failure in cattle, buffalo, goats, and other livestock. If any animals have recently been treated with these products and show signs of fever, swelling at the injection site, weakness, or loss of appetite, stop using the product immediately and consult a qualified veterinarian. Farmers should return the remaining stock to the supplier, distributor, or the nearest veterinary office. They are further advised to purchase veterinary medicines only from authorized dealers and ensure that the products bear clear batch numbers, expiry dates, and registration details issued by DRAP. For continued livestock health and to avoid losses, always store veterinary medicines properly, follow veterinary guidance for dosage, and report any suspected quality-related issues to the Provincial Livestock Department or DRAP through the official complaint channels. |
Model List of National Essential Medicines (2025) – Notification Dated 20-10-2025
Product Specification of Mecobalamin / Methylcobalamin Tablet
103. Recall Alert – Drug Products Declared Substandard.
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES
| DRAP Alert No | No II/S/10-25-103 |
| Action Date | 28 October, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratory from Province 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. | Injection Remedy Mecobalamin: 500mcg/ml (Reg. # 040385) | R-2411 & R-2419 | M/s Pak Risen Pharmaceuticals Plot No. 3, Block B, Phase I – II, Industrial Estate Hattar. (DML # 000573) | The sample is declared as “Sub-Standard” on the basis of Assay Test & “Adulterated” on the basis of identifying Cyanocobalamin (9.7 mcg/ml). |
| 2. | Injection Neocobal Mecobalamin: 0.5 mg/ML (Reg. # 071447) | S-2825 | M/s Pulse Pharmaceuticals (Pvt) Ltd. Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564) | The sample is declared as “Sub-Standard” on the basis of Assay Test & “Adulterated” on the basis of identifying Cyanocobalamin (0.106 mg/ml). |
| Risk Statement: | Administration of these defective injections may result in therapeutic failure, delayed neurological recovery, or persistence of deficiency symptoms, particularly among diabetic, anemic, elderly, and neuropathic patients who rely on Mecobalamin therapy for nerve regeneration and metabolic balance. In severe cases, the presence of unintended forms of Vitamin B12 (Cyanocobalamin) may lead to altered metabolic response or unexpected adverse effects in patients with impaired renal or hepatic function. |
| 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. |
102. Rapid Alert – Falsified / Spurious Veterinary Drug Products
Rapid Alert
CRACKDOWN AGAINST FALSIFIED / SPURIOUS VETERINARY DRUG PRODUCTS
| DRAP Alert No | No I/S/10-25-102 |
| Action Date | 27 October, 2025 |
| Target Audience | – Regulatory Field Force of DRAP and Provincial Drug Control departments. – Healthcare Professionals / Veterinarians – Consumers (Livestock owners, farmers, and animal caretakers) |
| Problem Statement | Drug Testing Laboratories from provinces, informed that the following Veterinary Drug products have been declared ‘spurious/falsified’ as its packaging falsely claims that it was manufactured by a licensed Veterinary pharmaceutical company which has formally disowned the said product. The details of report are as under |
The product identification details are as under: –
| S# | Product Name | Batch No. | Manufacturer | Remarks |
| 1. | Powder for inj. Penbiotic Procaine Penicillin ……. 1500,000 I.U, Benzyl Penicillin ……… 500,000 I.U, Streptomycin Sulphate … 5.0gm. | V01745 | Purported to be manufactured by M/s Nawan Laboratories (Pvt.) Ltd. 136, Sector 15, Korangi, Karachi. | The sample is declared as “Spurious” as per section 3(zb) (i) & (ii) of The Drugs Act 1976. |
| 2. | Powder for inj. PENIVET-5 Benzyl Penicillin ……… 500000IU Procaine Penicillin ……. 1500000IU Streptomycin Sulphate … 5g | VK-1496 | Purported to be manufactured by Star Laboratories (Pvt.) Ltd. (Animal Health Care Division) 23-Km, Multan Road, Lahore. | The sample is declared as “Spurious” as per section 3(zb) (i) & (ii) of The Drugs Act 1976. |
| 3. | Procaine Penicillin Inj.4.000,000 IU (Powder for injection) Each vial contains: Procaine Penicillín …. 3,000,000 I.U. Benzyl Penicillin …… 1,000,000 I.U. | 190315 | Purported to be manufactured by Shanghai Pharmaceutical Industry Corp. China. Shanghai P.R. China. M/S Shaheen Agency (Importer) disowned the given sample | The sample is declared as “Spurious” as per section 3(zb) (i) & (ii) of The Drugs Act 1976. |
| Risk Statement | The use of these spurious veterinary drug products poses a significant risk to animal health and indirectly to public health. Since the reported products were falsely labelled with the names of licensed manufacturers who have disowned them, their origin, composition, and sterility remain unknown. Administration of such falsified antibiotics in livestock may lead to therapeutic failure, severe infections, or toxicity in animals, and contributes to the emergence of antimicrobial resistance (AMR) due to exposure to sub-therapeutic or adulterated formulations. |
| 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 | Veterinary practitioners, pharmacists, and other healthcare professionals are strongly advised not to prescribe, dispense, or administer the above-mentioned batches of Veterinary drug products declared as spurious/falsified. Since these products do not originate from licensed manufacturers and their quality, safety, and efficacy cannot be assured, their use may result in ineffective therapy, treatment failure, or serious adverse reactions in animals. 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 | Livestock owners, farmers, and animal caretakers are strongly advised not to use or purchase the veterinary products mentioned above, as they have been declared spurious/falsified. These products falsely claim to be manufactured by licensed pharmaceutical companies, but their origin, quality, and safety are unknown, which means they may cause treatment failure, serious illness, or even death in animals. |
101. Recall Alert – Cream Kanadex-N (Batch # D7-22 & F7-27) – Substandard.
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES
| DRAP Alert No | No II/S/10-25-101 |
| Action Date | 24 October, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratory from Province 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. | Cream Kanadex-N Each gram contains: Dexamethasone-21 phosphate in the form of disodium salt …………………………… 1mg Neomycin in the form of sulphate………………. 3500I.U (Reg.# 012475) | D7-22 & F7-27 | M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126) | The sample is declared “Substandard” on the basis of the assay of Dexamethasone Phosphate (as disodium salt), and “Adulterated” on the basis of the identification and quantification of Dexamethasone (base) in HPLC analysis (0.343 mg/g), which is an undeclared active pharmaceutical ingredient not stated on the product label. |
| Risk Statement: | The presence of an undeclared corticosteroid, coupled with sub-therapeutic potency of the declared active ingredient, may lead to unpredictable clinical outcomes, including reduced therapeutic efficacy, skin atrophy, hormonal disturbances, or systemic corticosteroid exposure, especially with prolonged use. Patients suffering from eczema, dermatitis, and other inflammatory skin conditions, as well as children and individuals using topical steroids on large surface areas, are the most likely to be affected. The use of this defective product undermines treatment safety and effectiveness and may result in adverse dermatological or systemic effects. |
| 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. |
100. Recall Alert – Veterinary Drug Products Declared Substandard.
Recall Alert
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. |