Year: 2025
Draft Guideline for Lot Release of Human Vaccines, Blood Products (Plasma Derivatives Medicinal Products) and Anti-Sera (Edition 03)
Decisions of the 105th Meeting of the Medical Device Board (MDB) held on 23-10-2025 (Manual Applications)
108. Recall Alert (Veterinary Drug Product) – Melovetz 10 Injection (Batch # 2599063)
Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY, KARACHI.
| DRAP Alert No | No I/S/11-25-108 |
| Action Date | 12 November, 2025. |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers |
| Problem / Issue | Central Drugs Laboratory Karachi informed 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. | Melovetz 10 Injection Each 100 ml Contains: Meloxicam (B.P) ……. 10mg (Reg # 102021) | 2599063 | M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813) | Sample is Sub-Standard on the basis “Sterility test”. |
| Risk Statement: | Use of a non-sterile injectable veterinary preparation may cause local abscesses, septicemia, or systemic infections in treated livestock, leading to reduced productivity, illness, or death in affected animals. Such contamination also poses an indirect public health risk through the potential presence of harmful microorganisms or residues in milk and meat intended for human consumption. Therefore, the affected batch poses a significant risk to animal and public health and requires immediate recall and segregation from all levels of the supply chain. |
| 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 the affected batch of Melovetz 10 Injection (Batch No. 2599063) on their animals. Use of a non-sterile veterinary injection may cause swelling, abscess formation, fever, or serious infection in treated livestock. If any animals have recently been injected with this product and show unusual signs of illness, weakness, or loss of appetite, discontinue use immediately and consult a qualified veterinarian. The remaining stock of the affected batch should be returned to the supplier, distributor, or local veterinary office. Farmers are further advised to purchase veterinary medicines only from authorized sources, ensure that the packaging carries valid registration and batch details, and always check the expiry date and product integrity before use. Proper recordkeeping of veterinary products and prompt reporting of any suspected quality issues to the Provincial Livestock Department or DRAP are strongly encouraged to protect animal and public health. |
107. Recall Alert – (Class-I) Injection Isobaj (Batch # IB-0925)
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.
| DRAP Alert No | No I/S/11-25-107 |
| Action Date | 13 November, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Central Drugs Laboratory informed 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. | Isobaj Injection 10ml Each ml contains: Isosorbide Dinitrate ……. 1mg (Reg # 100721) | IB-0925 | M/s Bajwa Pharmaceuticals (Pvt) Ltd. 36-Km Lahore Gujranwala Road Khori District Sheikhupura. (DML # 000805) | Sample is Sub-Standard on the basis “Bacterial Endotoxin test”. |
| Risk Statement: | The sample of Isobaj Injection 10 mL (Batch No. IB-0925) has been declared “Substandard” on the basis of failure in the Bacterial Endotoxin Test, indicating the possible presence of pyrogenic contamination. Use of such injectable preparations may cause fever, chills, hypotension, or severe adverse reactions, particularly in hospitalized, cardiac, or elderly patients for whom this product is commonly prescribed. As the defect directly affects the safety and quality of the product, the batch poses a high public-health risk and warrants an immediate Class I recall, with retrieval of all distributed stock to prevent potential harm to 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. |
106.Recall Alert – (Class-III) Tablet Cekamol 500 mg (Batch # T-5014)
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES
| DRAP Alert No | No III/S/10-25-106 |
| Action Date | 12 November, 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. | Tablet Cekamol 500 mg Each Tablet Contains: Paracetamol ……. 500 mg (Reg. # 004268) | T-5014 | M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd. 50/28 Korangi Industrial Area Karachi. (DML # 000144) | The sample is “Substandard” with respect to physical characteristics observed. (White colored, round shaped, flat tablet with bevelled edges, have score line on one side and other side is engraved with “CKD”, packed in ALU/PVC blister of 1*10’s. Mmanufacture Sspecification claims that tablet should be round, flat and plain from both sides.) |
| Risk Statement: | The sample of Tablet Cekamol 500 mg (Batch No. T-5014) has been declared “Substandard” with respect to its physical characteristics, as the tablets bear engraving and a score line inconsistent with the approved product specifications. Although this deviation does not affect the safety, strength, or efficacy of the medicine, it indicates non-compliance with Good Manufacturing Practices (GMP) and approved appearance standards. The defect poses no direct risk to patient health; however, recall of the affected batch is recommended to maintain product quality and regulatory compliance.s. |
| 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. |
Minutes of the 349th Meeting of the Registration Board
Implementation of Pre-Import Clearance Mechanism under DRAP-PSW Gateway System for Import of Drugs (Raw Materials and Finished Products)
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. |