1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement
Drug Testing Laboratory (DTL), Government of Punjab has reported that the sample of the following drug product has been declared as “Spurious” under Section 3(z-b)(i) of the Drugs Act, 1976.
Purported to be manufactured by Hansel Pharmaceuticals (Pvt.) Ltd., Lahore
Declared Spurious, API not identified; assay 0%; fails identification test
Risk Statement
Use of this spurious injectable product may result in complete therapeutic failure and may expose patients to serious health risks, particularly in conditions requiring anabolic steroid therapy.
Action Initiated
The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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.
1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement
Drug Testing Laboratory (DTL), Government of Punjab has reported that the samples of the following drug products have been declared as “Spurious” under Section 3(z-b)(i) of the Drugs Act, 1976.
S#
Product Name
Batch
Manufacturer
Remarks
1
Dropha Tablets Each Tablet contains Dydrogesterone ……. 10mg
DRP-0011
Purported to be manufactured under M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, Karachi
(Dydrogesterone) is commonly prescribed for gynecological and obstetric indications. Use of a spurious product containing no active ingredient may result in therapeutic failure, leading to serious clinical consequences, including unmanaged hormonal conditions, pregnancy-related complications, and risk to maternal health.
Action Initiated
The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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 of Specified Batches of Curosurf (Poractant alfa) Intratracheal Suspension on Account of Microbial Contamination (Class II Recall)
DRAP Alert No
No II/S/04-26-19
Action Date
14 April, 2026.
Target Audience
· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue
The Drug Regulatory Authority of Pakistan (DRAP) has received a Rapid Alert notification from the World Health Organization (WHO) regarding quality defect (Class II recall) of Curosurf (Poractant alfa) Intratracheal Suspension (80 mg/ml) manufactured by M/s Chiesi Farmaceutici S.p.A., Italy. The defect has been identified by the State Institute for Drug Control (SUKL), Czech Republic, indicating a risk of microbial contamination in certain batches of the products. Review of distribution data confirms that the following batches have been supplied to Pakistan:
Therapeutic Goods (s) Affected: –
S#
Name of product
Batch #
Manufacturer details
Remarks
1.
Curosurf 1.5ml Vial(Pulmonary surfactant of Natural origin 80mg / ml – Corresponding to approx 74.0 of total phospholipids) Each vial contains: Poractant Alfa 120mg/1.5ml
Curosurf 3ml Vial(Pulmonary surfactant of Natural origin 80mg / ml – Corresponding to approx 74.0 of total phospholipids) Each vial contains: Poractant Alfa 240mg/3 ml
1226985
Risk Statement:
Curosurf (Poractant alfa) is indicated for the treatment of Respiratory Distress Syndrome (RDS) in premature infants. The identified defect relates to microbial contamination, which poses a serious sterility risk due to intratracheal administration. Use of affected batches may result in severe infections, treatment complications, and potentially life-threatening outcomes, particularly in premature neonates who are highly vulnerable. The most likely affected population includes neonates admitted in Neonatal Intensive Care Units (NICUs) requiring surfactant therapy. Healthcare professionals are advised to immediately discontinue use of affected batches and ensure availability of safe alternatives.
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 to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.
1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement
Atco Laboratories Limited, Karachi has intimated identification of suspected spurious batches of its registered products, namely Terbiderm Forte Tablet (Terbinafine 250 mg) and Glantrim Ophthalmic Solution, during market surveillance. Analytical testing conducted by the manufacturer’s Quality Control Laboratory confirmed that the Active Pharmaceutical Ingredient (API) content was not present in the tested samples. Comparative evaluation with retained samples further revealed significant discrepancies in packaging, labeling, and physical characteristics. Based on these findings, the following batches of these drug products have been found to be Spurious.
S #
Name of Product
Batch
Purported to be Manufactured by
Remarks
1
Terbiderm Forte Tablet (Terbinafine 250 mg) (Reg # 053367)
Terbinafine is indicated for treatment of fungal infections, while Glantrim Ophthalmic Solution is used in management of glaucoma and ocular hypertension. Laboratory findings confirm absence of active ingredients, resulting in complete therapeutic failure. Use of the mentioned batches of these drug products may lead to disease progression, treatment failure, and serious complications, particularly risk of vision-related complications in case of ophthalmic product. The public health risk is assessed as high.
Action Initiated
The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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 the mentioned batches of these drug 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.
– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue
M/s Glitz Pharma, 205, Muhammadi Plaza, College Road, Rawalpindi – Pakistan (Plant: Plot No. 265, Industrial Triangle Kahuta Road, Islamabad) has informed the Drug Regulatory Authority of Pakistan (DRAP) regarding voluntary recall of the following drug product due to quality defect observed during ongoing stability studies.
Therapeutic Goods (s) Affected: –
S#
Product Name
Batch
Manufacturers
Mfg. & exp. date
1.
Osilex D Manufacturing Date: August 2025
Expiry Date: July 2027.
T22125
M/s Glitz Pharma Plot No 265 Industrial Triangle Kahuta Road Islamabad. (DML # 000571)
The firm has initiated recall of the above-mentioned batch after observing changes in physical appearance during stability studies which do not comply with approved quality specifications.
Risk Statement:
The affected batch of Osilex D Tablet exhibited changes in physical appearance during stability studies. Although no adverse event has been reported, deviation from approved quality specifications may potentially compromise product quality, safety, and efficacy. The recall is being conducted as a precautionary measure to safeguard public health and ensure regulatory compliance.
Action Initiated
The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market.
Advice for Healthcare Professionals
DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –
All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).
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.
The sample has been declared “substandard” on the basis of dissolution test.
Risk Statement:
The above-mentioned batches of Santochlor Ophthalmic Solution (Chloramphenicol 5mg/ml) and Ciprozat Tablet (Ciprofloxacin 500mg) have been declared Substandard based on failure of assay and dissolution tests respectively. Substandard ophthalmic chloramphenicol may result in inadequate treatment of bacterial eye infections, leading to prolonged infection, worsening inflammation, or potential complications affecting vision. Substandard ciprofloxacin tablets may cause reduced therapeutic response in bacterial infections, increasing the risk of treatment failure, antimicrobial resistance, and disease progression. The most likely affected population includes patients suffering from eye infections and individuals being treated for bacterial infections, particularly those requiring timely and effective antibiotic therapy. Healthcare professionals are advised to discontinue use of the affected batches and ensure availability of quality-assured alternatives.
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 thislink.
-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.
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
DRAP Alert No
No I/S/03-26-15
Action Date
11 March, 2026.
Target Audience
· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue
Provincial Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as ‘Substandard’.
Therapeutic Goods (s) Affected: –
S#
Product Details
Batch
Manufacturer details
Remarks
1
Injection Micrise-1% 10 ml Each ml contains: Ivermectin …. 10 mg (Reg # 111206)
MR-087
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 Testfor related substances.
2.
Injection Wormec 1% 10 ml Each ml contains: Ivermectin …. 10 mg (Reg # 020802)
V00845
M/s Nawan Laboratories (Pvt) Ltd. 136 Sector 15 Korangi Industrial Area Karachi. (DML # 000442)
The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test.
Risk Statement:
The above-mentioned batches of Ivermectin Injection 1% (10 ml) have been declared Sub-Standard based on failure of Assay and Chromatographic Purity tests, indicating possible incorrect potency and/or presence of unacceptable impurities. Substandard veterinary ivermectin may lead to treatment failure in parasitic infections, persistent worm burden, development of drug resistance, and potential toxicity in animals. The most likely affected population includes livestock (cattle, sheep, goats) and other animals treated for internal and external parasites, particularly in farm settings where mass deworming is practiced.
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 to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.
The sample is “Substandard” on the basis of impurities test.
Risk Statement:
The above-mentioned products have been declared Substandard based on laboratory testing (pH and impurities failure). Substandard medicines may result in reduced therapeutic effectiveness, delayed recovery, or unexpected adverse reactions. Children suffering from diarrhea and gastrointestinal infections (Medizole Suspension) and pediatric patients using Montelukast sachets for asthma or allergic conditions are most likely to be affected. Treatment failure in these populations may lead to worsening of symptoms, increased risk of complications, and unnecessary escalation of therapy.
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 thislink.
-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.
1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement
Drug Testing Laboratory (DTL), Punjab vide Test Report No. 01-10096006005/DTL dated 21-02-2026 has declared Tablet D-Gest (Dydrogesterone 10 mg), labeled as manufactured by M/s Pharma Health Pakistan (Pvt.) Ltd., 17-Km Ferozepur Road, Lahore, as Spurious under Section 3(zb)(ii) of the Drugs Act, 1976, as laboratory analysis revealed that Dydrogesterone was not identified by FTIR and assay testing showed 0.0 mg per tablet against the labeled claim of 10 mg (specification limit 90–110%), indicating complete absence of the declared active pharmaceutical ingredient.
S#
Product Name
Batch
Manufacturer
Test Result
1
Tablet D-Gest (Dydrogesterone 10 mg)
DGH007
M/s Pharma Health Pakistan (Pvt) Ltd. 17-Km Ferozepur Road Lahore (DML # 000761)
Declared Spurious (API absent)
Risk Statement
Dydrogesterone is indicated for management of progesterone deficiency conditions including threatened miscarriage, menstrual disorders, and luteal phase support. Laboratory findings confirmed complete absence of the active ingredient, resulting in total therapeutic failure. Use of such product may lead to serious clinical consequences including pregnancy loss, hormonal imbalance, and failure of prescribed treatment. The public health risk is assessed as high, particularly in pregnant women and hormone-dependent patients.
Action Initiated
The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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.
1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement
Drug Testing Laboratory (DTL), Punjab vide Test Report No. 01-105013280/DTL dated 23-02-2026 has declared the following sample of product as Spurious under Section 3(zb)(ii) of the Drugs Act, 1976. The product is purported to be manufactured by M/s Getz Pharma (Pvt.) Limited, Karachi, Pakistan. However, the manufacturer has officially disowned the recovered sample and confirmed that the sealed sample has neither been manufactured nor sold by them. The firm has categorically declared the product counterfeit after physical comparison with their retention sample.
S#
Product Name
Batch
Manufacturer (as per label)
Test Result
1
Capsule Gabica 300 mg Each Capsule contains: Pregabalin 300 mg
518C27
Purported to be manufactured by M/s Getz Pharma (Pvt.) Limited, 29-30/27, K.I.A., Karachi, Pakistan
Declared Spurious
Risk Statement
Gabica (Pregabalin) 300 mg is indicated for neuropathic pain, epilepsy, and generalized anxiety disorders. Although laboratory testing showed compliance in assay and dissolution parameters, the manufacturer has confirmed that the recovered batch is counterfeit and not produced or marketed by them. Use of falsified pregabalin capsules may result in therapeutic inconsistency, treatment failure, or exposure to unknown manufacturing conditions. The circulation of counterfeit medicines poses a significant public health concern due to lack of regulatory oversight and quality assurance.
Action Initiated
The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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.
