RapidAlert – Drug Regulatory Authority of Pakistan

Rapid Alert


	SPURIOUS Nandrolone Injection 100mg/ml

DRAP Alert No	N^o I/S/04-26-21
Action Date	14 April, 2026
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 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.

S#	Product Name	Batch	Manufacturer	Remarks
1	Deka-Duralin Injection 100 mg/ml (Nandrolone Decanoate) Reg. No. 074187	H-191	*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.

20. Rapid Alert – SPURIOUS DYDROGESTERONE TABLETS

Salateen Philip Recall Alerts April 14, 2026April 14, 2026RapidAlert

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Rapid Alert


	SPURIOUS DYDROGESTERONE TABLETS

DRAP Alert No	N^o I/S/04-26-20
Action Date	14 April, 2026
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 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	Declared Spurious (API not detected, assay 0%, fails identification & dissolution.
2	Efaston Tablets 10 mg (Dydrogesterone)	4116	Purported to be manufactured under M/s Lahore Chemical & Pharmaceutical Works (Private) Limited. 137- Ferozepur Road, Lahore (DML# 000064).	Declared Spurious (API not detected, assay 0%, fails identification & dissolution.
3	Depasrone Tablets Each Tablet contains Dydrogesterone 10mg	2648	Purported to be manufactured under M/s Alpine Laboratories, Plot A-41, S.I.T.E., Karachi	Declared Spurious (API not detected, assay 0%, fails identification & dissolution.

Risk Statement	(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.

18. Rapid Alert – Spurious TERBIDERM FORTE TABLET (TERBINAFINE 250 mg) & GLANTRIM OPHTHALMIC SOLUTION

Salateen Philip Recall Alerts April 14, 2026April 20, 2026RapidAlert

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Rapid Alert


	SPURIOUS TERBIDERM FORTE TABLET (TERBINAFINE 250 mg) & GLANTRIM OPHTHALMIC SOLUTION

DRAP Alert No	N^o I/S/04-26-18
Action Date	14 April, 2026
Target Audience	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)	HH003L	M/s Atco Laboratories Limited, Karachi. B-18 S.I.T.E Karachi. (DML # 000188)	Spurious
2	Glantrim Ophthalmic Solution Timolol (as Maleate) …. 0.5%w/v Dorzolamide (As HCl) ……2%w/v (Reg # 050622)	LZ010K	Spurious

Risk Statement	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.

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

Salateen Philip Recall Alerts March 11, 2026March 11, 2026RapidAlert

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Rapid Alert


	SPURIOUS TABLET D-GEST DYDROGESTERONE 10 mg) (BATCH NO. DGH007)

DRAP Alert No	N^o I/S/03-26-13
Action Date	11 March, 2026
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 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.

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

Salateen Philip Recall Alerts March 11, 2026March 11, 2026RapidAlert

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Rapid Alert


	SPURIOUS CAPSULE GABICA 300 mg (BATCH NO. 518C27)

DRAP Alert No	N^o I/S/03-26-12
Action Date	11 March, 2026
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 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.

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

Salateen Philip Recall Alerts March 11, 2026March 11, 2026RapidAlert

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Rapid Alert


	SPURIOUS & SUBSTANDARD INJECTION VENOFER 5 mL (Batch No. 4721026AA)

DRAP Alert No	N^o I/S/03-26-11
Action Date	11 March, 2026
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 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 Name	Batch No.	Manufacturer (as per label)	Test Result
1	Injection Venofer 5 mL (Iron Sucrose 100 mg/5 mL)	4721026AA	*Purported to be manufactured by* Takeda Austria GmbH, Austria Imported by: M/s Searle Pakistan Limited	Declared 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 Statement	The 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 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.

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

Salateen Philip Recall Alerts March 11, 2026March 11, 2026RapidAlert

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	SPURIOUS INJECTION RHOPHYLAC 300 µg (BATCH NO. P100707423)

DRAP Alert No	N^o I/S/03-26-10
Action Date	11 March, 2026
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 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 Name	Batch No.	Manufacturer (as per label)	Test Result
1	Injection Rhophylac 300 µg (Human Anti-D (Rh) Immunoglobulin) Prefilled Syringe 2 ml (1500 IU / 300 µg)	P100707423	*Purported to be manufactured by:* M/s CSL Behring AG, Switzerland Imported/Distributed by: M/s Hakimsons (Impex) (Pvt.) Ltd., Karachi	Declared Spurious, Misbranded & Substandard (Sterility Failure)

Risk Statement	The 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 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.

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

Salateen Philip Recall Alerts March 11, 2026March 11, 2026RapidAlert

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Rapid Alert


	SPURIOUS CEFIXIME 400 mg CAPSULE (BATCH NO. LLM034)

DRAP Alert No	N^o I/S/03-26-09
Action Date	11 March, 2026
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 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 Name	Batch	Manufacturer	Test Result
1	Capsule CARICEF Cefixime Trihydrate equivalent to Cefixime …………400 mg (Reg # 022416)	LLM034	*Purported 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., Karachi	Declared Spurious

Risk Statement	The 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 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.

04. Rapid Alert – “Zetol” Unregistered Antiseptic product

Salateen Philip Recall Alerts February 18, 2026February 18, 2026RapidAlert

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Rapid Alert


	Unregistered Antiseptic Product “Zetol (Chloroxylenol) Germ Protection Liquid”

DRAP Alert No	N^o I/S/02-26-04
Action Date	18 February, 2026
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 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 Name	Manufacturer	Label Claim
Zetol Contains: Chloroxylenol Pack Size: 100 ml, 1 Liter Germ Protection Liquid / Antiseptic Liquid	UNCUS BROTHERS Address: 23 KM Multan Road, Lahore	Effective Protection against Germs that cause Infection”

Risk Statement	Use 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 Professionals	Healthcare 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 Consumers	Consumers 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

Salateen Philip Recall Alerts January 23, 2026January 23, 2026RapidAlert

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Rapid Alert

SPURIOUS (TABLET EFASTON 10mg) – Batch # 51062

DRAP Alert No	N^o I/S/01-26-136
Action Date	23 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 Statement	The 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 Statement	Efaston® (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 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 Professionals	Healthcare 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 Consumers	Consumers 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.

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