RapidAlert – Drug Regulatory Authority of Pakistan

45. Recall Alert (Carapamin Injection & Librax Tablet/Dragees)

Farooq Aslam Recall Alerts October 23, 2026October 23, 2026RapidAlert

Recall Alert


	DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB

DRAP Alert No	N^oI/S/10-26-45
Action Date	23rd October, 2026
Target Audience	– – National Regulatory Field Force – Healthcare Professional – Physician, Pharmacist, and Nurses at hospitals – General Public
Problem / Issue	Drug Testing Laboratory (DTL), Punjab has informed the Drug Regulatory Authority of Pakistan that samples of the below-mentioned drug products have been declared “Substandard” on the basis of Sterility Testing.

Sr. No.	Name of product	Batch Number	Name of Manufacturer	Remarks
1	Carapamin Injection 200mg (Dopamine HydrochlorideUSP) Reg. No. 060235	26A059	M/s Caraway Pharmaceuticals, plot # 12, St. N-3, National Industrial Zone (RCCI) Rawat, Islamabad (DML # 000629)	The sample is declared as Substandard on the basis of content of organic impurities found above the allowed limits by DTL Punjab, Lahore.
2	Librax Tablet (Chlordiazepoxide USP 5mg & Clinidium Bromide USP 2.5mg) Reg # 000568	001952	M/s Martin Dow Limited, plot # 37. Sector 19, Korangi Industrial Area, Karachi. (DML # 000267)	The sample is declared as Substandard on the basis of content of organic impurities found above the allowed limits by DTL Punjab, Faisalabad.

Therapeutic Goods (s) Affected: –

Risk Statement:	These products present a moderate to high public health risk, mainly affecting the general population, especially cardiac patients, allergy sufferers, children, and chronic medicine users. Moreover, the impurities may alter the stability of drug products and may cause formation of new complexes.
Action Initiated	The Provincial Drug Control departments and DRAP’s field offices have been asked 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 products 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 chemists 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 and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre.

44. Rapid Alert: Spurious/Falsified BREXIN TABLET

Farooq Aslam Recall Alerts October 22, 2026October 22, 2026RapidAlert

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	Spurious/Falsified Drug product (Brexin Tablet)

DRAP Alert No	N^o I/S/10-26-44
Action Date	22nd October, 2026
Target Audience	Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers
Problem Statement	Drug Testing Laboratory (DTL) Sindh, Karachi declared the following sample as Spurious/Falsified under Section 3(z-b) (ii) & 3(z-b) (i) of the Drugs Act, 1976. The sample was referred to DTL Sindh, Karachi, by the Area Provincial Inspector of Drugs, Karachi. The manufacturer has disowned the sample.

Sr. No.	Name of Product	Batch number	Name of Manufacturer	Remarks
1	Brexin Tablet	W68C	Purported to be manufactured by: M/s Glaxo Smith Kline Pakistan Ltd, F/268 SITE Karachi Under license of M/s Chiesi Farmaceutici S.p.A Pharma Italy.	The sample is declared as “Spurious” since it does not contain the active ingredient i.e. Piroxicam B-Cyclodextrin.

Risk Statement	Use of the above-mentioned products may result in treatment failure due to the absence of the declared active ingredient and may pose potential risks to patient safety.
Action Initiated	The Regulatory Field Force of DRAP and Provincial Drug Control Departments have 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.

43. Rapid Alert: Spurious/Falsified (Velosef 500mg tablet, Augmentin 625mg tablet, No-Spa Forte 80mg tablet, Mucaine Suspension)

Farooq Aslam Recall Alerts October 21, 2026October 27, 2026Alert, RapidAlert

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Rapid Alert


	Spurious/Falsified Drug products (Velosef 500mg tablet, Augmentin 625mg tablet, No-Spa Forte 80mg tablet, Mucaine Suspension)

DRAP Alert No	N^o I/S/10-26-43
Action Date	21st October, 2026
Target Audience	Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers
Problem Statement	Drug Testing Laboratory (DTL) Sindh, Karachi declared the following sample as Spurious/Falsified under Section 3(z-b) (ii) & 3(z-b) (i) of the Drugs Act, 1976. The sample was referred to DTL Sindh, Karachi, by the Area Provincial Inspector of Drugs, Karachi. The manufacturers have disowned the samples.

Sr. No.	Name of product	Batch Number	Name of manufacturer	Remarks
1	Velosef 500mg Capsule	LX3E	*Purported to be manufactured by:* GlaxoSmithKline Pakistan Ltd, plot 5, Sector 21, K.I.A Karachi	The sample is declared as “Spurious” since it does not contain the active ingredient i.e. Cephradine.
2	Augmentin 625mg tablet	YT9D	*Purported to be manufactured by:* GlaxoSmithKline Pakistan Ltd, F/268 SITE Karachi	The sample is declared as “Spurious” since it does not contain the active ingredient i.e. Amoxicillin Trihydrate & Clavulanic Acid.
3	No-Spa Forte 80mg tablet	AN010	*Purported to be manufactured by:* Hoechst Pakistan Limited, plot No. 23 Sec 22 Korangi Industrial Area Karachi	The sample is declared as “Spurious” since it does not contain the active ingredient i.e. Drotaverine Hydrochloride.
4	Mucaine Suspension	257A088	*Purported to be manufactured by:* Hoeschst Pakistan Limited, plot No. 23 Sec 22 Korangi Industrial Area Karachi	The sample is declared as “Spurious” since it does not contain the active ingredients

Risk Statement	Use of the above-mentioned products may result in treatment failure due to the absence of the declared active ingredients and may pose potential risks to patient safety.
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.

40. Rapid Alert: Spurious/Falsified Nasomet Aqueous Nasal Spray, Batch No. FW-099

Salateen Philip Recall Alerts October 19, 2026October 19, 2026RapidAlert

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	Spurious/Falsified Nasomet Aqueous Nasal Spray (Mometasone Furoate 50 mcg/spray), Batch No. FW-099

DRAP Alert No	N^o I/S/10-26-40
Action Date	19 October, 2026
Target Audience	Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers
Problem Statement	Central Drugs Laboratory, Karachi declared the following sample as Spurious/Falsified under Section 3(z-b) (ii) & 3(z-b) (ii) of the Drugs Act, 1976 The sample was referred to CDL, Karachi, by the Area Federal Inspector of Drugs, Karachi, on the grounds that it was suspected to be spurious. M/s Sante Sante (Private) Limited, A-97, SITE Superhighway, Karachi, has disowned the sample, stating that it does not belong to or originate from the said manufacturer.

S#	Product Name	Batch	Manufacturer (as per label)	Test Result
1	Nasomet Aqueous Nasal Spray Each Spray Contains: Mometasone Furoate …. 50 mcg (Reg # 108661)	FW-099	*Purported to be manufactured by:* M/s Sante (Private) Limited (DML # 000702) A-97, SITE Superhighway, Karachi.	Declared Spurious / falsified (Mometasone furoate not identified)

Risk Statement	Use of this product may result in treatment failure due to the absence of the declared active ingredient and may pose potential risks to patient safety.
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.

39. Rapid Alert . SPURIOUS AND UNREGISTERED ONCOLOGY PRODUCTS

Salateen Philip Recall Alerts July 29, 2026July 29, 2026RapidAlert

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	SPURIOUS AND UNREGISTERED ONCOLOGY PRODUCTS IDENTIFIED BY THE DRUG TESTING LABORATORY, SINDH (KARACHI)

DRAP Alert No	N^o I/S/07-26-39
Action Date	29 July, 2026
Target Audience	National Regulatory Field Force of DRAP and Provincial Drug Control Departments. Healthcare Professionals (Oncologists, Hematologists, Pharmacists & Nurses). Hospitals and Oncology Treatment Centres. General Public.
Problem Statement	The Drug Testing Laboratory Sindh, Karachi, under the Provincial Government Analyst, has reported the following oncology drug products were declared Spurious/unregistered, as laboratory identification confirmed the absence of the declared active pharmaceutical ingredient, as defined under Section 3(z)(b)(i) read with Section 23(1)(a)(i) & (vii) of the Drugs Act, 1976.

S#	Product	Batch No.	Manufacturer	Identification Result	Classification
1	Leukeran-2mg Tablet	512900	Excella GmbH & Co. KG, Feucht, Germany	Chlorambucil (confirmed)	Unregistered
2	Sarafenib/Sorafenib-200mg Tablet (Soraclog)	GST56925-C	Globela Pharma (Pvt) Ltd, Surat, India	Sorafenib Tosylate — Not Identified	Spurious & Unregistered
3	Arimidex-1mg Tablet	B2417	Haupt Pharma Münster GmbH, Germany	Anastrozol (confirmed)	Unregistered
4	Lenvaxen 4 Capsule	26ALV04004	Everest Pharmaceutical Ltd, Narayanganj, Bangladesh	Lenvatinib Mesylate (confirmed)	Unregistered
5	Cyclophosphamide-50mg Tablet	OT0470	Kwality Pharmaceutical Ltd, Kangra, India	Cyclophosphamide not Identified	Spurious & Unregistered
6	Gefimed-250mg Tablet	25GST016	Globela Pharma (Pvt) Ltd, Surat, India	Gefitinib (confirmed)	Unregistered
7	Lenvatinib-10mg Capsule (Lenvalieva)	C25LN03B3	Allieva Pharma (Pvt) Ltd, Baddi, Himachal Pradesh, India	Lenvatinib Mesylate (confirmed)	Unregistered
8	Lenalidomide-10mg Capsule	OC0090	Kwality Pharmaceutical Ltd, Kangra, India	Lenalidomide (confirmed)	Unregistered
9	Nintedanib Soft Gelatin Capsule (Nindanib 150)	24250052	Glenmark Pharmaceuticals Ltd, Daman, India	Nintedanib Ethanesulfonate (confirmed)	Unregistered

Risk Statement	These are high-value oncology therapeutics (chemotherapy, targeted kinase inhibitors, and hormonal cancer agents) used for the treatment of leukaemia, breast cancer, hepatocellular carcinoma, renal cell carcinoma, multiple myeloma, and related malignancies. Unregistered products have bypassed DRAP’s quality, safety, and efficacy evaluation and therefore carry unverified risk. In the products declared spurious, laboratory testing found the stated active ingredient was not identified, meaning the product may deliver no therapeutic effect at all. Use of these products in cancer patients by an already immunocompromised and vulnerable population may result in treatment failure, disease progression, and potentially life-threatening outcomes.
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.

38. Rapid Alert – Falsified JAKAVI® (Ruxolitinib) Tablets

Salateen Philip Recall Alerts July 16, 2026July 16, 2026RapidAlert

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	Falsified JAKAVI® (Ruxolitinib) Tablets Identified in the WHO Eastern Mediterranean and European Regions

DRAP Alert No	N^o I/S/07-26-38
Action Date	16 July, 2026
Target Audience	National Regulatory Field Force of DRAP and Provincial Drug Control Departments. Healthcare Professionals (Oncologists, Hematologists, Pharmacists & Nurses). Hospitals and Oncology Treatment Centres. General Public.
Problem Statement	The Drug Regulatory Authority of Pakistan (DRAP) has received WHO Medical Product Alert No. 2/2026 regarding falsified JAKAVI® (ruxolitinib) tablets identified in the WHO Eastern Mediterranean and European Regions. The falsified products were detected in the Islamic Republic of Iran, Türkiye, and the Russian Federation after being illicitly sold through online platforms and, in at least one instance, supplied through a pharmacy. The genuine manufacturer, Novartis Pharma AG, has confirmed that the following batch numbers are not genuine. Any JAKAVI® product bearing these batch numbers should be considered falsified and should not be used.

S#	Name of Product	Batch No.	Manufacturer Details	Remarks
1	JAKAVI® (Ruxolitinib) Tablets 20 mg	AVT50	Manufacturer: Novartis Pharma AG, Lichtstrasse 35, CH-4056 Basel, Switzerland	Falsified Product
2	JAKAVI® (Ruxolitinib) Tablets 15 mg	FNR06	Manufacturer: Novartis Pharma AG, Lichtstrasse 35, CH-4056 Basel, Switzerland
3	JAKAVI® (Ruxolitinib) Tablets 15 mg	SGL04	Manufacturer: Novartis Pharma AG, Lichtstrasse 35, CH-4056 Basel, Switzerland

Risk Statement	JAKAVI® (ruxolitinib) is indicated for the treatment of myelofibrosis, polycythaemia vera, and graft-versus-host disease following stem cell transplantation. The identified products are falsified medical products. Novartis has confirmed that the above-mentioned batch numbers are not valid. Laboratory analysis of a sample from batch AVT50 confirmed the absence of the declared active ingredient (ruxolitinib). Additionally, visual discrepancies were identified in the packaging, including the absence of batch numbers on blister strips of certain falsified batches. Use of these falsified products may result in treatment failure, disease progression, increased morbidity, and potentially life-threatening outcomes. Patients receiving JAKAVI® often have compromised immune systems, making them particularly vulnerable to ineffective or falsified medicines.
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.

37. Rapid Alert – Falsified DARZALEX (Daratumumab) Injection

Salateen Philip Recall Alerts July 16, 2026July 16, 2026RapidAlert

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	Falsified DARZALEX (Daratumumab) Injection Identified in WHO Regions of the Americas and South-East Asia

DRAP Alert No	N^o I/S/07-26-37
Action Date	16 July, 2026
Target Audience	National Regulatory Field Force of DRAP and Provincial Drug Control Departments. Healthcare Professionals (Oncologists, Hematologists, Pharmacists & Nurses). Hospitals and Oncology Treatment Centres. General Public.
Problem Statement	The Drug Regulatory Authority of Pakistan (DRAP) has received a Medical Product Alert No. 3/2026 issued by the World Health Organization (WHO) regarding falsified DARZALEX (Daratumumab) Injection identified in the WHO Regions of the Americas and South-East Asia. The falsified products were detected in Maldives and Mexico after being supplied through non-authorized distributors, with at least one report indicating supply to hospitals. The genuine manufacturer, JANSSEN, has confirmed that the following batch numbers are not valid and any DARZALEX product bearing these batch numbers should be considered falsified.

S#	Name of Product	Batch No.	Stated Manufacturer	Remarks
1	DARZALEX (Daratumumab) Injection 400 mg/20 mL	STV1K01	Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.	Falsified Product
2	DARZALEX (Daratumumab) Injection 100 mg/5 mL	MYS7381		Falsified Product

Risk Statement	DARZALEX (daratumumab) is a monoclonal antibody indicated for the treatment of multiple myeloma and amyloid light-chain (AL) amyloidosis. No laboratory testing has been performed on the falsified products and their identity, composition, quality, and sterility remain unknown. These products may contain no active ingredient, incorrect ingredients, or harmful substances, making them ineffective or potentially dangerous. WHO has also reported the presence of visible particulate matter in one falsified batch (STV1K01), indicating a potential risk of contamination. Use of these products may result in treatment failure, disease progression, infections, injection-related complications, increased morbidity, and potentially life-threatening outcomes.
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.

33. Rapid Alert – SPURIOUS DRUG PRODUCTS (NOVIDAT 500MG Tablets and TONOFLEX-P Tablets)

Salateen Philip Recall Alerts June 3, 2026June 3, 2026RapidAlert

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	SPURIOUS DRUG PRODUCTS (NOVIDAT 500MG Tablets and TONOFLEX-P Tablets)

DRAP Alert No	N^o I/S/06-26-33
Action Date	03 June, 2026
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	The Drug Regulatory Authority of Pakistan (DRAP) has received test and analysis reports from the Provincial Drug Testing Laboratory, Punjab, regarding the following drug products sampled from the market. The laboratory has declared the products Spurious under Section 3(zb)(i) of the Drugs Act, 1976. Further investigation conducted by the manufacturer, SAMI Pharmaceuticals (Pvt.) Ltd., confirmed that the products were not manufactured by the company and are falsified/spurious.

S#	Product Name	Batch	Manufacturer	Remarks
1	NOVIDAT 500mg Tablets Ciprofloxacin HCl equivalent to Ciprofloxacin 500mg (Reg. No. 011837)	139N086	*Purportedly manufactured under license of* SAMI Pharmaceuticals (Pvt.) Ltd., Karachi	Spurious. Assay result showed 0.00 mg/tablet against the stated strength of 500 mg/tablet.
2	TONOFLEX-P Tablets Tramadol HCl 37.5mg + Paracetamol 325mg (Reg # 067163)	248N105		Spurious. Assay results showed 0.00 mg/tablet for both active ingredients against the stated strengths of 37.5 mg and 325 mg, respectively.

Risk Statement	The presence of spurious medicines containing no detectable active pharmaceutical ingredients poses a serious risk to public health due to treatment failure, disease progression, and potential harm to patients relying on these products. Healthcare professionals and supply chain stakeholders are advised to remain vigilant and immediately report any information regarding the availability or distribution of the above-mentioned batches.
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.

32. Rapid Alert – SPURIOUS / FALSIFIED DANZEN DS TABLETS

Salateen Philip Recall Alerts June 2, 2026June 2, 2026RapidAlert

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	SPURIOUS / FALSIFIED DANZEN DS TABLETS

DRAP Alert No	N^o I/S/06-26-31
Action Date	02 June, 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 SPURIOUS under Section 3(z-b)(i) & (ii) of the Drugs Act, 1976, based on the laboratory findings and confirmation received from the manufacturer.

S#	Product Name	Batch	Manufacturer	Remarks
1	DANZEN® DS Tablets (Serratiopeptidase 10 mg) Reg. No. 028173	4476	*Purportedly manufactured under license of* Helix Pharma (Pvt.) Ltd., Karachi.	Declared Spurious by DTL; Serratiopeptidase not identified; Assay 0%; Manufacturer has confirmed the sample was not manufactured by Helix Pharma and has disowned the batch.

Helix Pharma (Pvt.) Ltd. has formally communicated to the regulatory authorities that the submitted sample was not manufactured by the company. Following a comparative investigation against its reference sample.

S.#	Parameters	Reference Sample (Danzen DS 10mg Batch No. 4476)	Manufacturer Portion / spurious (Danzen DS 10mg Batch No. 4476)
01	Color of Tablet	Color of tablet observed dark pink with smooth coating as compare to Warrantor sample.	Color of tablet observed different.
02	Color of Blister Strip	Color of blister observed Blue.	Color of blister observed different as dark blue.
03	Font size and Style of Embossed Batch number and Expiry	Font size and style of embossed batch number and expiry observed as per standard font size.	Font size and style of embossed batch number and expiry observed different as compare to reference standard sample.

Risk Statement	Laboratory analysis conducted by Drug Testing Laboratory, Punjab revealed that Serratiopeptidase, the declared active pharmaceutical ingredient, could not be identified in the tested sample. Assay testing demonstrated complete absence of the declared active ingredient, with results showing 0.0 mg/tablet against the labeled claim of 10 mg/tablet. Use of this counterfeit/spurious product may result in: Complete therapeutic failure. Failure to achieve the intended anti-inflammatory effect. Delay in appropriate treatment and recovery. Exposure to unknown or undeclared ingredients of uncertain quality, safety and efficacy. Potential adverse health consequences arising from the use of falsified medicines.
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.

31. Rapid Alert – SPURIOUS / FALSIFIED BREXIN TABLETS 20 mg

Salateen Philip Recall Alerts June 2, 2026June 2, 2026RapidAlert

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	SPURIOUS / FALSIFIED BREXIN TABLETS 20 mg

DRAP Alert No	N^o I/S/06-26-31
Action Date	02 June, 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 under Section 3(z-b)(i) & (ii) of the Drugs Act, 1976, based on the laboratory findings and confirmation received from the Marketing Authorization Holder, the sample of the following drug product is considered a Falsified/spurious.

S#	Product Name	Batch	Manufacturer	Remarks
1	Brexin Tablets 20 mg (Piroxicam-β-Cyclodextrine) Reg. No. 010637	1207863	*Purportedly manufactured under license of* Chiesi Farmaceutici S.p.A., Parma, Italy	Declared Spurious by DTL; Piroxicam not identified; Assay 0%; Marketing Authorization Holder has confirmed that the sample is not a genuine Chiesi product and has disowned the batch.

M/s Chiesi Pharmaceuticals (Pvt.) Ltd., Pakistan, the authorized marketer of Brexin in Pakistan, has formally communicated to the regulatory authorities that the seized sample was neither manufactured under license of Chiesi Farmaceutici S.p.A., Italy, nor marketed or distributed through its authorized supply chain. The company has also identified multiple packaging discrepancies between the seized sample and authentic Brexin tablets and has categorically disowned the product as counterfeit/spurious.

Brexin (Chiesi)	Brexin (Spurious/Counterfeit)
Unit carton is sealed with transparent tape on both closure sides	Unit carton is not sealed with tape of Chiesi specifications
Font (Size & Style) is specific for Chiesi	Font (Size & Style) is different
Variable data is printed through Inkjet printer	Variable data is pre-printed
Tablet color is pale yellow	Tablet color is dark yellow or pigmented at some spots
Aluminum foil is specific for Chiesi	Aluminum foil is shiny which is not Chiesi specifications
Blister color is off white	Blister color is white
Printing of variable data on blister is Chiesi specific	Stamping of variable data is different than Chiesi printed
Leaflet color is white printed on imported paper	Leaflet color is pale yellow local paper

Risk Statement	Laboratory analysis conducted by Drug Testing Laboratory, Punjab, revealed that the declared active pharmaceutical ingredient (Piroxicam) could not be identified in the sample. Assay results demonstrated 0.0% content of Piroxicam against the labeled claim of 20 mg per tablet, indicating complete absence of the declared active ingredient. Use of this counterfeit/spurious product may result in: Complete therapeutic failure in patients requiring anti-inflammatory and analgesic treatment. Delay in appropriate medical management due to false reliance on ineffective therapy. Potential exposure to unknown or undeclared ingredients of uncertain quality, safety, and efficacy. Increased risk of adverse health outcomes, particularly in patients suffering from painful inflammatory conditions.
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.

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