Safety Info

47. Rapid Alert: Falsified INFLUENZA VACCINE VAXIGRIP TETRA (BATCH # Y4B34)

Farooq Aslam Recall Alerts October 27, 2026October 27, 2026Recall

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Rapid Alert

	Falsified INFLUENZA VACCINE VAXIGRIP TETRA (BATCH # Y4B34)

DRAP Alert No	No I/S/10-26-47
Action Date	27th October, 2026
Target Audience	Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers
Problem Statement	M/s Hoechst Pakistan Limited, Plot No. 23, Sector 22, Korangi Industrial Area, Karachi has informed that a Falsified drug product i.e. Vaxigrip Tetra, Quadrivalent Influenza Vaccine (Batch No. Y4B34) has been found to be available in the market.

Sr. No.	Name of Product	Batch number	Name of Manufacturer	Remarks
1	Vaxigrip Tetra Vaccine (Suspension for Injection in Pre-filled Syringe)	Y4B34	Purported to be manufactured by: M/s Sanofi Winthrop Industrie, France	The suspected batch i.e. Y4B34 has never been imported or distributed in Pakistan.

Risk Statement	The use of above-mentioned Falsified Vaccine i.e. Vaxigrip Tetra (Batch # Y4B34) may pose serious safety and quality concerns for Public Health
Action Initiated	The Regulatory Field Force of DRAP and Provincial Drug Control Departments have been asked to conduct surveillance activities throughout the supply chain to confiscate the falsified product.
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 above-mentioned product 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.

46. Recall Alert: Substandard Cikina Umblical Cord Clamp

Farooq Aslam Recall Alerts October 27, 2026October 27, 2026Recall

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	MEDICAL DEVICES DECLARED (CIKINA UMBLICAL CORD CLAMP SUBSTANDARD BY DRUG TESTING LABORATORY PUNJAB, Rawalpindi

DRAP Alert No	No I/S/10-26-46
Action Date	27 October, 2026
Target Audience	– National Regulatory Field Force – Healthcare Professional – Physician, Pharmacist, and Nurses at hospitals – General Public
Problem / Issue	Drug Testing Laboratory Punjab, Rawalpindi has informed Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical device have been declared “Substandard” on the basis of Sterility Testing.

Sr. No.	Product Name	Name of Manufacturer/Importer	Batch Number	Remarks
1	CIKINA UMBILICAL CORD CLAMP (UMBILICAL CORD CLAMP) MDIR: 0003486	M/s Ningbo Greatcare Trading Co. Ltd, China; Marketed by: Al-Hamd Enterprises, FL-11/1/1, Block 6, Gulshan e Iqbal Karachi Karachi (ELI # 00285)	25495	The sample is SUBSTANDARD on the basis of Sterility test.

Therapeutic Goods (s) Affected: –

Risk Statement:	The sterility failure of the umbilical cord clamp may result in exposure of neonatal patients to microbial contamination. Due to the vulnerable patient population, inability of the user to detect the defect, and potential for serious infection including sepsis, the residual risk is considered unacceptable and requires immediate corrective and regulatory action.
Action Initiated	The field force of DRAP and Provincial Drug Control Departments have been asked to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements.
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 batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –	All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products.
Advice for Consumers	Consumers and healthcare facilities in possession of the affected batches should immediately stop using the above-mentioned 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.

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

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

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	DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB

DRAP Alert No	No I/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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Rapid Alert

	Spurious/Falsified Drug product (Brexin Tablet)

DRAP Alert No	No 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	No 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.

42. Recall Alert: SUBSTANDARD & MISBRANDED CLINIC DISPOSABLE SYRINGES 20ML BY M/S SURGI PLAST, GADOON AMAZAI, KPK

Farooq Aslam Recall Alerts October 20, 2026October 20, 2026Recall

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	MEDICAL DEVICES (SYRINGES) DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES MANUFACTURED BY M/S SURGI PLAST, GADOON AMAZAI, KPK

DRAP Alert No	No I/S/10-26-42
Action Date	08 June, 2026
Target Audience	– – National Regulatory Field Force – Healthcare Professional – Physician, Pharmacist, and Nurses at hospitals – General Public
Problem / Issue	Drug Testing Laboratory, Lahore has informed the Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical devices (Syringes) have been declared “Substandard” on the basis of Sterility Testing and Misbranded on the basis of labelling as two needle gauges are mentioned on label.

Sr. No.	Product Name	Name of Manufacturer/Importer	Batch Number	Remarks
1	CLINIC Disposable Syringes 20mL	M/s SURGI PLAST Plot # 78, Road no. L-4, Industrial Estate Gadoon Amazai, KPK. (ELM-0030)	20-01G-25	The sample is SUBSTANDARD on the basis of Sterility test and MISBRANDED on the basis of labelling as two needle gauges are mentioned on label.

Therapeutic Goods (s) Affected: –

Risk Statement:	The syringes may pose a risk of infection or other harm because they failed sterility testing. The label also lists two different gauges, which may lead to selection or use of the wrong syringe size. The use of a non-sterile syringe could introduce microorganisms into the patient, potentially causing local or systemic infection. The conflicting gauge information may also result in incorrect device selection, affecting the intended procedure or medication delivery.
Action Initiated	The field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements.
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 batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –	All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products.
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.

41. Recall Alert: WFI (Batch # W-174), M/s City Pharmaceutical Laboratories (DML#00723)

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

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	DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert No	No I/S/07-26-36
Action Date	14 July, 2026
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Testing Laboratory, Karachi informed that the samples of diluent i.e. Water for Injection (Batch # W-174) in the combo-pack of the below mentioned drug products have been declared as ‘Substandard’ based on presence of visible particles.

Therapeutic Goods (s) Affected: –

Sr. No.	Product Name	Batch Numbers	Manufacturers
1.	Exoran-500mg Injection vial	P-240 P-239	M/s City Pharmaceutical Laboratories, Plot 12-A, I-5, Sector 5, Korangi Industrial Area, Karachi (DML No. 00723).
2.	Exoran-1g Injection vial	P-252 P-251	M/s City Pharmaceutical Laboratories, Plot 12-A, I-5, Sector 5, Korangi Industrial Area, Karachi (DML No. 00723).
3.	Exit 500mg injection	P-829 P-828	M/s City Pharmaceutical Laboratories, Plot 12-A, I-5, Sector 5, Korangi Industrial Area, Karachi (DML No. 00723).
4.	Exit 1g injection	P-1107 P-1106 P-1105 P-1104	M/s City Pharmaceutical Laboratories, Plot 12-A, I-5, Sector 5, Korangi Industrial Area, Karachi (DML No. 00723).

The details of Substandard water for injection ire as follows:

Sr. No.	Product Name	Batch No.	Manufacturers	Remarks
1.	Water for Injection	W-174	M/s City Pharmaceutical Laboratories, Plot 12-A, I-5, Sector 5, Korangi Industrial Area, Karachi (DML No. 00723).	The sample has been declared as “Substandard” based on presence of particles visible to naked eye.

Risk Statement:	TThese findings indicate a high public health risk, primarily affecting hospitalized patients and vulnerable groups. The most likely to be harmed are neonates, children, elderly patients, immunocompromised individuals, post-surgical patients, and those receiving IV therapy. Substandard Water for injection containing particles visible to the naked eye may cause bloodstream infections, septic or pyrogenic reactions, and potentially fatal complications. Particles may also contribute to embolic or inflammatory complications. The greatest risk is in intensive care, emergency, and other clinical settings where sterile injectable products are essential.
Action Initiated	The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market.
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above-mentioned products along with the other drug products containing Water For Injection (Batch No.: W-174) are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information about 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 along with the other drug products containing Water For Injection (Batch No.: W-174). The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).
Advice for Consumers	Consumers should stop using products bearing the affected batch number(s) and containing water for injection (Batch No.: W-174) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using the drug products, and report the incident to Drug Regulatory Authority of Pakistan/ National Pharmacovigilance Centre.

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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Rapid Alert

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

DRAP Alert No	No 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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Rapid Alert

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

DRAP Alert No	No 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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Rapid Alert

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

DRAP Alert No	No 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.

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