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13. Rapid Alert – SPURIOUS TABLET D-GEST DYDROGESTERONE 10 mg) (BATCH NO. DGH007)

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SPURIOUS TABLET D-GEST DYDROGESTERONE 10 mg) (BATCH NO. DGH007)
DRAP Alert NoNo I/S/03-26-13
Action Date11 March, 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug 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 NameBatchManufacturerTest Result
1Tablet D-Gest (Dydrogesterone 10 mg)DGH007M/s Pharma Health Pakistan (Pvt) Ltd. 17-Km Ferozepur Road Lahore (DML # 000761)Declared Spurious (API absent)
Risk StatementDydrogesterone 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 InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.

12. Rapid Alert – SPURIOUS CAPSULE GABICA 300 mg (BATCH NO. 518C27)

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SPURIOUS CAPSULE GABICA 300 mg (BATCH NO. 518C27)
DRAP Alert NoNo I/S/03-26-12
Action Date11 March, 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug 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 NameBatchManufacturer (as per label)Test Result
1Capsule Gabica 300 mg
Each Capsule contains:
Pregabalin 300 mg		518C27Purported to be manufactured by
M/s Getz Pharma (Pvt.) Limited,
29-30/27, K.I.A., Karachi, Pakistan		Declared Spurious
Risk StatementGabica (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 InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.

11. Rapid Alert – SPURIOUS & SUBSTANDARD INJECTION VENOFER 5 mL (Batch No. 4721026AA)

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SPURIOUS & SUBSTANDARD INJECTION VENOFER 5 mL (Batch No. 4721026AA)
DRAP Alert NoNo I/S/03-26-11
Action Date11 March, 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug Testing Laboratory (DTL), Punjab has declared the following sample of product as Spurious under Section 3(zb)(ii), Misbranded under Section 3(s)(vi), and Substandard under the Drugs Act, 1976.
S#Product NameBatch No.Manufacturer (as per label)Test Result
1Injection Venofer 5 mL (Iron Sucrose 100 mg/5 mL)4721026AAPurported to be manufactured by Takeda Austria GmbH, Austria Imported by: M/s Searle Pakistan LimitedDeclared Spurious, Misbranded & Substandard (Assay failure of Iron & Sucrose)

The product is purported to be manufactured by Takeda Austria GmbH, Austria and imported by M/s Searle Pakistan Limited. However, the authorized importer has officially disowned the recovered sample and confirmed, after physical comparison with their retention sample of the same batch, that the provided sample is counterfeit.

Laboratory analysis revealed failure of assay for Iron and Sucrose contents, while sterility test complied. The product also does not contain finished drug product specifications.

Risk StatementThe product is a Human Anti-D (Rh) Immunoglobulin injection indicated for prevention of Rh isoimmunization in Rh-negative individuals. Laboratory testing revealed microbial growth in sterility testing, indicating contamination and rendering the product unsafe for parenteral administration. Additionally, the batch has been confirmed as falsified and not legally imported by the authorized distributor. Administration of this contaminated and spurious biological product may lead to serious bloodstream infections, therapeutic failure in prevention of Rh sensitization, and life-threatening complications. The public health risk is assessed as high, particularly for pregnant women and immunocompromised patients.
Action InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.

10. Rapid Alert – Spurious Injection RHOPHYLAC 300 µg (Batch # P100707423)

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SPURIOUS INJECTION RHOPHYLAC 300 µg (BATCH NO. P100707423)
DRAP Alert NoNo I/S/03-26-10
Action Date11 March, 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug Testing Laboratory (DTL), Punjab vide Test Report No. 01-105012931/DTL dated 06-02-2026 has declared the following sample as Spurious under Section 3(zb)(ii) of the Drugs Act, 1976. The product is purported to be manufactured by M/s CSL Behring AG, Switzerland and imported/distributed by M/s Hakimsons (Impex) (Pvt.) Ltd., Karachi; however, verification from the stated importer confirms that the recovered batch does not belong to them and was not legally imported.
The sample also failed Sterility Test (Membrane Filtration Method) and was additionally categorized as Substandard on sterility grounds and Misbranded with respect to labeling.
S#Product NameBatch No.Manufacturer (as per label)Test Result
1Injection Rhophylac 300 µg (Human Anti-D (Rh) Immunoglobulin) Prefilled Syringe 2 ml (1500 IU / 300 µg)P100707423Purported to be manufactured by: M/s CSL Behring AG, Switzerland Imported/Distributed by: M/s Hakimsons (Impex) (Pvt.) Ltd., KarachiDeclared Spurious, Misbranded & Substandard (Sterility Failure)
Risk StatementThe product is a Human Anti-D (Rh) Immunoglobulin injection indicated for prevention of Rh isoimmunization in Rh-negative individuals. Laboratory testing revealed microbial growth in sterility testing, indicating contamination and rendering the product unsafe for parenteral administration. Additionally, the batch has been confirmed as falsified and not legally imported by the authorized distributor. Administration of this contaminated and spurious biological product may lead to serious bloodstream infections, therapeutic failure in prevention of Rh sensitization, and life-threatening complications. The public health risk is assessed as high, particularly for pregnant women and immunocompromised patients.
Action InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.

09. Rapid Alert – SPURIOUS CEFIXIME 400mg CAPSULE (Batch # LLM034)

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SPURIOUS CEFIXIME 400 mg CAPSULE (BATCH NO. LLM034)
DRAP Alert NoNo I/S/03-26-09
Action Date11 March, 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug Testing Laboratory (DTL), Punjab has declared following sample of product as ‘Spurious’ purported to be manufactured/marketed by the stated manufacturer, however, upon laboratory analysis and comparison with the genuine QC retention sample, it has been determined that the product is not the authentic product of the registered manufacturer and is therefore classified as spurious under the Drugs Act, 1976.

Following product is being marketed and sold in Pakistan without prior registration/enlistment with the Drug Regulatory Authority of Pakistan (DRAP)

S#Product NameBatchManufacturerTest Result
1Capsule CARICEF Cefixime Trihydrate equivalent to Cefixime …………400 mg (Reg # 022416)LLM034Purported to be manufactured by: M/s Healthtek (Pvt.) Ltd., Plot No. 14, Sector 19, Korangi Industrial Area, Karachi Marketer SAMI Pharmaceuticals (Pvt.) Ltd., F-95, S.I.T.E., KarachiDeclared Spurious
Risk StatementThe subject product has been declared Spurious, as laboratory analysis confirmed absence of the stated active ingredient (Cefixime), resulting in complete therapeutic failure. Packaging comparison with the genuine manufacturer’s QC retention sample revealed significant discrepancies in printing, hologram security features, blister demarcation, and labeling details, confirming it is not an authentic product. Use of this falsified antibiotic may lead to disease progression, complications, and increased antimicrobial resistance. The risk to public health is assessed as high, particularly for patients requiring effective antibacterial therapy.
Action InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.

04. Rapid Alert – “Zetol” Unregistered Antiseptic product

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Unregistered Antiseptic Product “Zetol (Chloroxylenol) Germ Protection Liquid”  
DRAP Alert NoNo I/S/02-26-04
Action Date18 February, 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug Testing Laboratory, Punjab informed that samples of the below-mentioned products have been found unregistered and declared Substandard and Misbranded under the Drugs Act, 1976 and Drugs (Labeling & Packing) Rules, 1986.

Following product is being marketed and sold in Pakistan without prior registration/enlistment with the Drug Regulatory Authority of Pakistan (DRAP)

Product NameManufacturerLabel Claim
Zetol Contains: Chloroxylenol Pack Size: 100 ml, 1 Liter Germ Protection Liquid / Antiseptic LiquidUNCUS BROTHERS Address: 23 KM Multan Road, LahoreEffective Protection against Germs that cause Infection”
Risk StatementUse of the unregistered antiseptic product “Zetol (Chloroxylenol) Germ Protection Liquid” may pose a potential risk to public health, as it has not been evaluated or approved by DRAP for its quality, safety, and efficacy.
The product contains an active antiseptic substance (Chloroxylenol) and is being marketed with infection-prevention claims without regulatory authorization.
Furthermore, its presentation closely resembles an already registered antiseptic brand (Dettol), which may mislead consumers and increase the risk of inappropriate use of an unregulated product.
Therefore, continued distribution and use of this product may result in:
exposure to substandard or contaminated formulations
misleading therapeutic claims
consumer deception and confusion
potential adverse skin reactions or ineffective infection control.
Action Initiated·         Provincial Drug Control Authorities and DRAP Field Forces have been directed to initiate immediate enforcement action, including market surveillance, seizure, and recall of the affected batch.
·         Further regulatory action is being taken in accordance with applicable laws.
Advice for Healthcare ProfessionalsHealthcare professionals, pharmacists, and healthcare institutions are advised to:
·         Not recommend, prescribe, dispense, or use the unregistered antiseptic product “Zetol (Chloroxylenol) Germ Protection Liquid” in any clinical or household setting.
·         Ensure that only DRAP registered/enlisted antiseptic and disinfectant products are procured and supplied to patients and the general public.
·         Be vigilant for any adverse skin reactions, irritation, or lack of expected antiseptic effect associated with the use of this product and report such events through the Pharmacovigilance/Vigilance system.

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 ConsumersConsumers are advised to:
·         Stop using the unregistered antiseptic product “Zetol (Chloroxylenol) Germ Protection Liquid” immediately.
·         Do not purchase or rely on this product for infection prevention, as it has not been evaluated or approved by DRAP for quality, safety, or effectiveness.
·         Be cautious of products that closely resemble well-known registered brands (such as Dettol), as such resemblance may be misleading.
·         If you have experienced any skin irritation, allergic reaction, or other adverse effects after using this product, consult a healthcare professional and report the event to the relevant health authorities.
·         Purchase antiseptic and disinfectant products only from reputable sources and ensure they are registered/enlisted with DRAP.

136. Rapid Alert – Spurious Tablet EFASTON – Batch # 51062

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SPURIOUS (TABLET EFASTON 10mg) – Batch # 51062

DRAP Alert NoNo I/S/01-26-136
Action Date23 January , 2026
Target Audience·         Regulatory Field Force of DRAP and Provincial Drug Control departments.
·         Healthcare Professionals (Gynecologists, Obstetricians, Pharmacists, Drug Distributors, Hospitals, Clinics,)
·         Consumers (General Public)
Problem StatementThe Drug Regulatory Authority of Pakistan has been informed through an official test/analysis report issued by the Drug Testing Laboratory, Government of the Punjab, that a sample of Efaston® (Dydrogesterone) 10 mg film-coated tablets (Reg. # 064835), Batch No. 51062, manufactured by Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd., Lahore (DML # 000064), has been declared SPURIOUS under Section 3(zb)(i) of the Drugs Act, 1976. Laboratory analysis confirmed that the declared active ingredient Dydrogesterone was not identified, and assay results showed 0.0 mg per tablet, despite a labeled strength of 10 mg.

The product identification details are as under: –

Risk StatementEfaston® (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 InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified product.

·         The product has been declared SPURIOUS under the Drugs Act, 1976.
·         Provincial Drug Control Authorities and DRAP Field Forces have been directed to initiate immediate enforcement action, including market surveillance, seizure, and recall of the affected batch.
·         Further regulatory action is being taken in accordance with applicable laws.
Advice for Healthcare ProfessionalsHealthcare professionals are advised to immediately stop prescribing, dispensing, or using Efaston® (Dydrogesterone) 10 mg, Batch No. 51062. All available stock should be verified to ensure procurement from  authorized sources only, and any suspected presence of the affected batch in the supply chain must be promptly reported to DRAP or the concerned Provincial Drug Control Authorities. In addition, patients who may have received the said product should be appropriately identified, monitored, and managed clinically in accordance with standard medical practice.
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 ConsumersConsumers are advised not to use Efaston® (Dydrogesterone) 10 mg tablets of Batch No. 51062. If this product is currently being used, patients should immediately consult their healthcare provider for appropriate medical advice and further management. Medicines should only be purchased from licensed pharmacies, and any suspected or doubtful products should be promptly reported to the concerned drug inspectors or to DRAP.

135. Rapid Alert – Unregistered OMNIVISC 2% (Substandard & Misbranded)

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Unregistered, Substandard /Misbranded – OMNIVISC 2%

DRAP Alert NoNo I/S/01-26-135
Action Date21 January , 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug Testing Laboratory, Punjab informed that samples of the below-mentioned products have been found unregistered and declared Substandard and Misbranded under the Drugs Act, 1976 and Drugs (Labeling & Packing) Rules, 1986.

The product identification details are as under: –

S#Product NameBatch No.ManufacturerRemarks
1.Omnivisc 2% (HPMC) Ophthalmic Solution USP, 5 mLOMV190171(purported to be manufactured by)
M/s Omni Lens Pvt. Ltd.,
Plot No. 17, Ambota, Sector-5, Parwanoo Distt. Solan (H.P.), India		The sample has been declared Substandard on the basis of failed sterility test (Non-sterile) and Misbranded due to labeling discrepancies including mismatch of batch number on labels, absence of Pakistan Drug Registration Number, absence of Urdu instructions, and non-mentioning of maximum retail price.
2Omnivisc 2% (HPMC) Ophthalmic Solution USP, 5 mLOMV191171(purported to be manufactured by)
M/s Omni Lens Pvt. Ltd.,
Plot No. 17, Ambota, Sector-5, Parwanoo Distt. Solan (H.P.), India		The sample has been declared Substandard on the basis of failed sterility test (Non-sterile) and Misbranded due to absence of Pakistan Drug Registration Number, incomplete labeling particulars including Urdu instructions and maximum retail price, in violation of Drugs Act, 1976 and Drugs (Labeling & Packing) Rules, 1986.
Risk StatementThe use of Omnivisc 2% (HPMC) Ophthalmic Solution, Batches OMV190171 and OMV191171, poses a serious and vision-threatening public health risk due to failure of sterility testing, rendering the product non-sterile, and due to misbranding. Ophthalmic preparations are required to be sterile, and the use of a non-sterile eye product may lead to severe ocular infections, including conjunctivitis, keratitis, endophthalmitis, corneal ulceration, and potential irreversible loss of vision or blindness. The absence of proper labeling information, including DRAP’s Drug Registration Number and usage instructions in Urdu, increases the risk of misuse, inappropriate dosing, prolonged use, and delayed medical intervention. Patients undergoing eye surgery, those with corneal injuries, contact lens users, and immunocompromised individuals are at particularly high risk. Continued circulation and use of these batches may therefore result in serious ocular morbidity, warranting immediate regulatory action and strict removal from the supply chain.
Action InitiatedThe 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 ProfessionalsHealthcare professionals, including ophthalmologists, general practitioners, pharmacists, and nursing staff, are advised to exercise heightened vigilance regarding the use and supply of Omnivisc 2% (HPMC) Ophthalmic Solution, Batch Nos. OMV190171 and OMV191171. They should immediately discontinue prescribing, dispensing, or administering these batches and ensure their removal from institutional and retail inventories. Patients who may have been exposed to these products should be clinically evaluated for signs of ocular infection or adverse reactions, particularly post-operative eye patients and contact lens users.
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 ConsumersConsumers are strongly advised to immediately stop using Omnivisc 2% (HPMC) Ophthalmic Solution, particularly Batch Nos. OMV190171 and OMV191171, and to check product labels and batch numbers carefully. Any remaining stock should be isolated and returned to the point of purchase and not used further. Individuals who have already used these eye drops and experience symptoms such as eye redness, pain, discharge, blurred vision, sensitivity to light, or worsening of eye condition should seek immediate medical attention from an ophthalmologist. Patients who have recently undergone eye surgery, suffered eye trauma, or have underlying eye infections are at higher risk and should be especially vigilant. Consumers are also encouraged to report the product and any suspected adverse effects to the relevant health authority to help prevent further harm and protect public health.

128. Rapid Alert – Eventone-C Creams & LUFA Advanced Pain Relief Gel Containing Unauthorized Pharmaceutical Ingredient(s)

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Unregistered and Falsified Cosmetic Cream Containing Unauthorized Pharmaceutical Ingredient(s)

DRAP Alert NoNo I/S/01-26-128
Action Date14 January , 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementCentral Drugs Laboratory (CDL) Karachi informed that Laboratory analysis of Below mentioned Cream, marketed for skin fairness and treatment of skin darkness (cosmetic products) & a Gel marketed for pain relief, confirmed the presence of steroids (prescription-only corticosteroid). These products were being marketed as a cosmetic without declaring this pharmaceutical ingredient and without registration or authorization from the Drug Regulatory Authority of Pakistan (DRAP).
The presence of a potent medicinal substance in a cosmetic product constitutes misrepresentation of identity, composition, and regulatory status, rendering the product an Unregistered and Falsified Drug Product under the Drugs Act, 1976.

The product identification d

S#Product NameBatch No.ManufacturerRemarks
1.Eventone-C Cream12706M/s Pharma Health Pakistan Pvt. Ltd.  The sample has been declared “Un-registered/falsified” under the Drugs Act 1976 because Hydrocortisone has been identified as suspected by Federal Inspector of Drugs.  
2LUFA Advanced Pain Relief Gel25C372M/s ASR Global Traders  The sample has been declared “Un-registered/falsified” under the Drugs Act 1976 because Betamethasone has been identified as suspected by Federal Inspector of Drugs.  

etails are as under: –

Risk StatementThe identification of hydrocortisone in Eventone-C Cream and betamethasone in LUFA Advanced Pain Relief Gel, both of which are prescription-only corticosteroids, in products being marketed without registration or authorization poses a serious public health risk. Use of these substances without medical supervision may result in skin thinning, steroid-induced acne, pigmentation disorders, delayed wound healing, suppression of local immunity, masking of infections, and worsening of underlying skin diseases. As these products are falsely presented as ordinary cosmetic and topical preparations, users are unknowingly exposed to potent pharmaceutical agents, increasing the risk of prolonged misuse, dependency, and irreversible skin damage, particularly in women, children, and long-term users.

Action InitiatedThe 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 ProfessionalsDRAP 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 ConsumersParents, caregivers, pharmacies, retailers, and online sellers are strongly advised to immediately check product names and batch numbers, stop use and sale of affected batches, and remove them from circulation. Consumers who have already used these products and observe any adverse symptoms in infants should seek immediate medical attention and report the case to the relevant health authority.
This alert is issued in the interest of public health and infant safety, and dissemination through healthcare facilities, pharmacies, online platforms, and social media is strongly recommended.

127. Rapid Alert – Falsified Duphalac Syrup (Batch # 251986127 )

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CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED DUPHALAC SYRUP 100 ML

DRAP Alert NoNo I/S/12-25-127
Action Date30 December, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementThe Drug Testing Laboratory (DTL), Punjab has informed the Drug Regulatory Authority of Pakistan that a sample of the below-mentioned drug product has been declared spurious upon analysis.
The contract manufacturer, M/s Highnoon Laboratories Ltd., 17.5 Km Multan Road, Lahore (DML No. 000155), for the genuine registration/marketing authorization holder, M/s Abbott Laboratories (Pakistan) Ltd., Karachi, of Duphalac Syrup, has confirmed that the impugned batch was not manufactured by them and is therefore spurious.
The product is purported to be manufactured by M/s Abbott Laboratories Co., Canada, and has been declared “Unregistered (Falsified)”.

The product identification details are as under: –

S#Product NameBatch No.ManufacturerRemarks
1.Syrup Duphalac 100ml Each 100 ml contains: Lactulose ……. 66.7 g  251986Purported to be manufactured by M/s Abbott Laboratories Co. Canada.  The sample has been declared “Spurious” as per Section 3(zb)(i) & (ii) of the Drugs Act 1976.  
Risk StatementThe circulation of a spurious and unregistered Duphalac Syrup (Lactulose) poses a significant risk to public health, particularly to pediatric patients, elderly individuals, and patients with chronic constipation or hepatic disorders, who are the primary users of this product. As the impugned batch was not manufactured by the authorized contract manufacturer and lacks regulatory oversight, there is a heightened risk of incorrect composition, contamination, reduced or excessive strength, and therapeutic failure, which may lead to worsening of disease, electrolyte imbalance, dehydration, or other serious adverse health outcomes.

Action InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.