Year: 2025
RECALL ALERT – -VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No I/S/09-25-71 |
| Action Date | 17 September, 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 VARIAX 100ML EACH ML CONTAINS: VITAMIN A 15.000 I , VITAMIN D3 1,000 IU, VITAMIN E 20MG, VITAMIN B1 10MG, VITAMIN B SODIUM PHOSPHATE 5MG, VITAMIN B6 3MG. NICOTINAMIDE 35MG, PANTOTHENOL 25MG, VITAMIN B12 50MCG | EI-1654 | M/s. Eterna Pharma (Pvt) Ltd. Plot No. 99, 100, 101 &198-C, Sector D1, Old Industrial Estate, Mirpur, AJK Pakistan. (DML # 000923) | ‘Adulterated’ with respect to Assay test performed for Vìtamin B1 and is “Adulterated” as defined under clause (iv) of sub-section (a) of section 3 of The Drugs Act, 1976 as it contains Ascorbic Acid, Ambrosic Acid and Peiminine as ingredients other than the labelled ingredients. |
| 2 | Ivermex Injection 100 mL Each ml contains Ivermectin …. 10 mg | IV348 | M/s Wimits Pharmaceuticals (Pvt) Ltd. Plot No. 129 Sundar Industrial Estate Lahore. (DML # 000789) | ‘Substandard’ quality on the basis of the result of test for related substance, sterility & assay of Ivermectin. |
| 3 | PRIMOX injectable suspension 50mL Each ml contains amoxicillin (as trihydrate) …. 150 mg | PP9789 | M/s Prix Pharmaceutical (Pvt) Ltd. Plot No. 5 Pharmacity 30-Km Multan Road Lahore. (DML # 000587) | ‘Substandard’ quality on the basis of the result of sterility test. |
| 4 | Injection Lumpyvac 50 After reconstitution, each 2ml dose contains: Attenuated Lumpy Skin Disease Virus (Neethling strain) ……. ≥103.5 TCID50 Diluent for Lumpy Skin Disease Vaccine for Cattle (For Veterinary Use) Potassium Chloride 0.2mg Potassium Phosphate monobasic 0.2 mg Sodium Chloride 0.8mg, Sodium Phosphate dibasic 1.14mg per 2 mL (Reg # 111128) | 25/LSD/01 | Importer: M/s Huzaifa International. Commercial Area, Aziz Bhatti Town, Dist. Sargodha. Manufacturer: Vetal animal Health Product S.A Organize Sanayi Bolgesi, Petrol Mah. 14. Cad. No. 01, Adiyamam, Turkey | ‘Substandard’ on the basis of the result of sterility test. |
| 5 | Injection Oxytocin 50ml Oxytocin 10 IU/Ml Reg# 014564 | V-06725 | M/s Venus Pharma. 23-Km Multan Road. Lahore. (DML # 000300) | ‘Substandard’ on the basis of the result of sterility test. |
| 6 | Injection Oxytovetz 50ml Oxytocin (USP) … 10 IU/mL Reg. # 111468 | 25129639 | M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813) | ‘Substandard’ on the basis of the result of sterility test. |
| Risk Statement: | Use of the above-mentioned veterinary drug products poses serious risks to animal health and public safety: · Treatment failure and loss of therapeutic efficacy in livestock. · Microbial contamination leading to sepsis and animal deaths. · Ineffective vaccination against Lumpy Skin Disease, increasing risk of outbreaks. · Adverse economic impact on farmers due to animal health losses. Food safety risks through compromised milk and meat supply chains. |
| 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. |
SPURIOUS / FALSIFIED MEDICINE DETECTED – DAIZELIVE INJECTION 2ML (DIAZEPAM 10MG/2ML, CLAIMED)
Rapid Alert
SPURIOUS / FALSIFIED MEDICINE DETECTED – DAIZELIVE INJECTION 2ML (DIAZEPAM 10MG/2ML, CLAIMED)
| DRAP Alert No | No I/S/09-25-70 |
| Action Date | 17th September, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Directorate of Drugs Control Punjab informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared as ‘Spurious’. |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Injection Daizelive 2ml Each 2ml ampoule contains: Diazepam …… 10 mg | DZ44 | M/s Liven Pharmaceuticals (Pvt) Ltd. Sray Road, 49 KM, Multan Road, Phool Nagar, District Kasur (DML # 000881) | Drug Testing Laboratory, Rawalpindi has declared the sample as ‘spurious’ since it does not contain the claimed active ingredient (Diazepam) and instead contains an undeclared ingredient (Chlorpheniramine Maleate 45.283 mg/2ml). |
| Risk Statement | Laboratory testing has confirmed that the product labeled as Daizelive Injection 2ml (Diazepam 10mg/2ml) is spurious/falsified, as it does not contain Diazepam, instead contains Chlorpheniramine Maleate (45.283mg/2ml). Use of this falsified product poses a serious and life-threatening risk, particularly for patients requiring Diazepam for seizures, severe anxiety, or emergency care, as they will not receive the intended treatment. Healthcare professionals and the public are strongly advised to immediately discontinue use of this product, ensure recall compliance, and report any suspected adverse outcomes or suspicious stock to DRAP. |
| 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. |
Recall Alert – DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No I/S/09-25-69 |
| Action Date | 15 September, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1 | SN DOL Suspension 60ml. Each 5ml contains: Paracetamol ……… 120 mg | 917 | M/s SNB Pharma (Pvt) Ltd. Plot No. 142 Industrial Estate Hayatabad Peshawar. (DML # 000759) | ‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit. |
| 2 | SALBOVENT Oral syrup 60ml Each 5ml contains Salbutamol (as sulphate) .. 2mg | L25D52 | M/s Synchro Pharmaceuticals. 77-Industrial Estate Kot Lakhpat Lahore. (DML # 000575) | ‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit. |
| 3 | RESGYL Suspension 60 ml Each 5ml contains Benzoyl Metronidazole equivalent to Metronidazole ………… 200 mg | 4E566 | M/s Rasco Pharma (Pvt) Ltd. 5.5 Km Raiwind Road Ali Razabad, Lahore. (DML # 000530) | ‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit. |
| 4 | Tablet Daisy 10 mg Each film coated tablet contains Cetirizine Dihydrochloride USP ………………………….10mg | 258084 & 258085 | M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537) | ‘Substandard’ on the basis of Test for impurities (Organic impurities). |
| 5 | Colchis Capsules Each Hard Gelatin Capsule contains: Thiocolchicoside ……….4 mg | 15 | M/s Akson Pharmaceuticals (Pvt) Ltd. Plot No. 9B-1 & 2 Sector D-1 Old Industrial Estate Mirpur Azad Kashmir. (DML # 000486) | ‘Substandard’ on the basis of Assay and uniformity of weight. |
| 6 | AQUA-P Injection (Sterile Water for Injection 5mL) | P-676 P-677 | M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551) | Drug Testing Laboratory, Lahore declared the sample as ‘substandard’ quality on the basis of the result of test for bacterial endotoxins. |
| 7 | Sterile Water for Injection 10ml Each Glass Ampoule contains: WFI …………………. 10mL | 084L24 | M/s Brookes Pharma (Pvt) Ltd. Plot No. 58-59 Sector No. 15 Korangi Industrial Area Karachi. (DML # 000275) | ‘Substandard’ on the basis of Bacterial Endotoxins Test. |
| 8 | Sterile Water for injection 5 ml Each Glass Ampoule contains: WFI …………………. 5 ml | 130 | M/s Wilshire Laboratories (Pvt) Ltd. 124/1 Industrial Estate Kot Lakhpat Lahore. (DML # 000232) | ‘Substandard’ on the basis of Bacterial Endotoxins Test. |
| Risk Statement: | The above drug products have been declared substandard / adulterated due to toxic impurities, undeclared ingredients, assay failures, sterility issues, and bacterial endotoxins. Their use may cause treatment failure, harmful side effects, or serious health risks including infections and toxicity. Children, elderly, hospitalized, and immunocompromised patients are at greater risk. The public and healthcare providers are advised to stop use and return the affected batches immediately. |
| 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. |
RAPID ALERT – CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS
Rapid Alert
CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS
| DRAP Alert No | No I/S/09-25-68 |
| Action Date | 17th September, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’ as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Purported Manufacturer | Remarks |
| 1. | Azomax 500mg (Azithromycin 500mg) | C1699 | Purported to be manufactured by AGP Limited Karachi | Spurious (Does not contain active ingredient) |
| 2. | Klaricid 500mg tablet (Clarithromycin 500mg) | 722269XV | Purported to be manufactured by Abbott Laboratories Karachi | Spurious (Does not contain active ingredient) |
| Risk Statement | All the above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/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. |
RAPID ALERT – CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS
Rapid Alert
CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS
| DRAP Alert No | No I/S/09-25-67 |
| Action Date | 17th September, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’ as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Purported Manufacturer | Remarks |
| Dytron Tabelt 10mg (Dydrogesterone 10mg) | D1T | Purported to be manufactured by an unlicensed /illegal entity claimed to be Pax Pharmaceuticals Karachi | Spurious (Does not contain active ingredient) | |
| Levontis 375mg (Amoxicillin trihydrate: 250, Clavulanic Acid: 125mg) | LF2 | -do- | Spurious (Does not contain active ingredient) | |
| Levontis 625mg (Amoxicillin trihydrate: 500, Clavulanic Acid: 125mg) | LF2 | -do- | Spurious (Does not contain active ingredient) | |
| Levontis 625mg (Amoxicillin trihydrate: 875, Clavulanic Acid: 125mg) | LF4 | -do- | Spurious (Does not contain active ingredient) | |
| Sulfira suspension (Sucralfate 1g/5ml) | SL6 | -do- | Spurious (Does not contain active ingredient) | |
| Furin 50mcg aerosol spray (Mometasone Furoate 50mcg) | NF4 | -do- | Spurious (Does not contain active ingredient) | |
| Droxel capsule 500mg (Cefadroxil Monohydrate 500mg)) | RC5 | -do- | Spurious (Does not contain active ingredient) | |
| Bromiz tablet (Bromazepam 3mg) | 0007 | Purported to be manufactured by an unlicensed /illegal entity claimed to be Miraz Pharma Kasur (Fictitious firm) | Spurious (Does not contain active ingredient) |
| Risk Statement | All the above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/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. |
Falsified Vigamox® Ophthalmic Solution – Batch VHF02A (Not from Authorized Source)
Rapid Alert
Falsified Vigamox® Ophthalmic Solution – Batch VHF02A (Not from Authorized Source)
| DRAP Alert No | No I/S/09-25-66 |
| Action Date | 17th September, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Novartis Pharma (Pakistan) Ltd., Karachi informed DRAP that falsified Vigamox® Sterile Ophthalmic Solution bearing Batch # VHF02A is identified in the Pakistani market. The reported batch number is not imported, manufactured, or supplied by Novartis Pharma (Pakistan) Ltd., i.e. the genuine registration holder in Pakistan. The packaging falsely uses the Novartis name and branding, but it does not come from the authorized supply chain. |
| Risk Statement | In the case of Vigamox® (Batch No. VHF02A), such falsification may result in ineffective treatment of bacterial eye infections, potential worsening the infection, and risk of serious eye damage or vision loss. This alert applies only to Batch No. VHF02A and does not affect other batches of Vigamox® in the market supplied by the authorized registration holder. The falsified batch poses a particular risk to patients with eye infections, especially children, the elderly, and those with weakened immune systems, who may experience rapid deterioration if untreated or improperly treated. |
| 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. |
Minutes of 97 & 98 meeting of the Medical Device Board
Recall Alert: Lipidem® / Lipoplus® Emulsion for Infusion (Product Stability Risk)
Recall Alert
Lipidem® / Lipoplus® Emulsion for Infusion (Zone IV Stability Risk for Pakistan)
| DRAP Alert No | No I/S/09-25-65 |
| Action Date | 17 September, 2025. |
| Target Audience | · Hospitals (Public & Private): especially those with ICU, surgical, oncology, and nutrition support units. · Parenteral Nutrition Centre / Clinical Nutrition Teams: where lipid emulsions are routinely administered. · Pharmacists: particularly hospital pharmacists and those in charge of sterile/IV admixtures. · Physicians: especially intensivists, anesthesiologists, gastroenterologists, and pediatricians using parenteral nutrition. · Provincial Health Authorities & Regulatory Bodies: to ensure monitoring and enforcement at the provincial level. · Importer & Distributors: of Lipidem® / Lipoplus® in Pakistan. · Nursing Staff: involved in IV infusion preparation and administration. |
| Problem / Issue | Stability studies conducted by the manufacturer and German regulatory authority identified droplet-like agglomerates (subvisual fat particles) in Lipidem® / Lipoplus® emulsions stored at 25°C beyond 12 months. These agglomerates, if infused without appropriate filtration, may lead to serious adverse events, including fat embolism in pulmonary capillaries. The details of the product is as under: – |
Therapeutic Goods (s) Affected: –
| S# | Reg. # | Name of Drug(s) & Composition | Packing | Shelf Life | Importer details |
| 1. | 099492 | Lipoplus Emulsion for Intravenous Infusion Each 1000 ml contains: Medium chain triglycerides…. 100gm Soya oil …………………… 80gm Omega-3-acid triglycerides… ….20gm (As per Innovator’s Specification)* | 250m1 Glass Bottle | 02 years | M/s B.Braun Pakistan (Pvt) Ltd, The Forum, Suite 216 Khayaban-e-Jami, Clifton Block 9, Karachi. Godown address: Ground Floor Plot No. C-153, S-6F, Mehran Town, Karachi. |
| Risk Statement: | In stability studies conducted in Germany, droplet-like agglomerates were detected in Lipidem® / Lipoplus® emulsions stored at 25 °C beyond 12 months. To mitigate this risk under those conditions, the German authority recommended the use of a 1.2 µm lipid infusion filter during administration. Since Pakistan falls under Zone IV climatic conditions (hot and humid), which differ significantly from Germany (25°C), the risk of earlier onset of agglomerate formation cannot be excluded. To date, no stability information or scientific justification for Zone IV conditions has been provided by the manufacturer or Marketing Authorization Holder (MAH). Considering these factors and the higher temperature and humidity in Pakistan, the matter is classified as a Class I recall risk, as the defect may reasonably be expected to cause serious adverse health consequences if not managed appropriately. |
| 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 (Class-II) – Drug Products Declared substandard by Directorate of Drugs Control Punjab (DDCP)
Recall Alert
| DRAP Alert No | No II/S/09-25-64 |
| Action Date | 15 September, 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 samples of below mentioned products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Tablet Ortizin 10mg Each film coated tablet contains: Cetirizine 2HCl ……10 mg | 24L377 | M/s Obsons Pharmaceuticals. 209-S Industrial Estate Kot Lakhpat Lahore. (DML # 000416) | DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of assay and impurities testing. |
| 2. | Tablet Daisy 10 mg Each film coated tablet contains: Cetirizine 2HCl ……10 mg | 25B084 & 25B085 | M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore. (DML # 000537) | DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of impurities testing (Organic impurities). |
| 3. | Tablet Ascard 75 Each enteric coated tablet contains: Acetyl Salicylic acid …. 75 mg | AR076K | M/s Atco Laboratories Limited. B-18 S.I.T.E Karachi. (DML # 000188) | DDCP Alert No. l73/2025 declared the sample as ‘substandard’ on the basis of test for related substance (Impurity C: Salicylic Acid). |
| 4. | Tablet Bytec 10mg Each film coated tablet contains: Cetirizine 2HCl ……10 mg | E604, E605 & E606 | M/s Batala Pharmaceuticals. 23/B Small Industrial Estate No. 2 Gujranwala. (DML # 000477) | DDCP Alert No. l79/2025 declared the sample as ‘substandard’ on the basis of impurities testing. |
| 5. | Tablet Vivin 10 mg Each film coated tablet contains: Cetirizine 2HCl ……10 mg | 315 | M/s Murfy Pharmaceuticals (Pvt) Ltd. 8-Km Raiwind Road Lahore. (DML # 000543) | DDCP Alert No. l79/2025 declared the sample as ‘substandard’ on the basis of impurities testing. |
| Risk Statement: | The above-mentioned batches of tablets have been declared substandard due to failure in assay and impurities testing, including elevated levels of related substances. Use of these defective medicines may lead to reduced therapeutic effect, unpredictable side effects, and potential toxicity. Patients, pharmacists, and healthcare providers are advised to discontinue the affected batches immediately and report any adverse events to DRAP. |
| 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. |