Rapid Alert; Drug Product: Unregistered and Falsified Hyp-Rho-D injection (Rho(D) immune globulin Injection

Rapid Alert

Unregistered and Falsified Hyp-Rho-D injection (Rho(D) immune globulin Injection

DRAP Alert NoNo  I/S/08-23-30
Action DateAugust 02, 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
4. General Public
Problem StatementThe Provincial Inspector of Drugs in Mansehra obtained a sample of the Hyp-Rho-D Injection from M/s. Abdullah Medical Store, located inside the Naseem Surgical Center, Upper Chennai Abbottabad Road, Mansehra. This particular product is not registered with the DRAP and is suspected to be falsified.
The product detail as under: –

Therapeutic Goods Affected:-

SrProduct NameCompositionBatch #Mfg. DateExp. DateManufactured by
(as stated on label)
Remarks
1Hyp-Rho-D Injection
 
Registration No: Nil
Rho (D) immunoglobulin (Human) for injection09181943Aug-2024M/s. Woolmar Chemical Corporation, USA.

Importer / Distributor:
Ms. Zaryab Traders Lahore.
The product is not registered and is also suspected to be falsified.
Risk Statement:The product claimed to contain immune globulin (anti-D immune globulin or RhIG), which is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. The claimed product is unregistered which infers that the quality and safety attributes of the product are not accepted and approved by DRAP. Unregistered Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the product are unknown.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.

-Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.

Rapid Alert: Medical Devices; Unregistered Intravenous Medical Devices in the market

Rapid Alert

Unregistered Intravenous Medical Devices in the Market

DRAP Alert NoNo  I/S/08-23-31
Action Date10th August 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
4. General Public
Problem StatementThe Medical Device Rules 2017 provides the regulatory framework for medical devices in the country. SRO 224(I)/2023 dated 27-02-2023 extended the transition period for the registration of medical devices to licensed importers and manufacturers as per risk-based classifications. However, medical devices specified in Schedule D and E of this SRO are always mandatory to be registered with DRAP before marketing in the country. DRAP has received reports/complaints that some unregistered medical devices (e.g., IV cannulas, infusion sets, syringes, etc.) are being proliferated in the open market.

The product detail as under: –

Therapeutic Goods Affected:-

SrProduct NameManufacturer/importer
(as stated on label)
Illustration of unregistered medical devices
1Euro Plus Infusion SetApex Medical Devices

2Chiron Infusion SetNot mentioned
3Health Plus Infusion SetNot mentioned
4O’Divine Infusion SetNot mentioned
5Cath-Tec I.V CannulaNilhol Enterprises
East Lane Business Park Wemby, UK
6Healthflon I.V. CannulaHealthylife medical equipment Trading,
Alfajar Business Centre, airport road, Dubai, UAE
Risk Statement:The use of unregistered medical devices poses significant risks to patients as they may not meet the necessary standards of safety, quality, and performance. Such medical devices can be nonsterile, or their sterility can be compromised from damage during shipping and storage. The hazards associated with the use of unregistered medical device includes inaccurate or unreliable results, Infection or other adverse reactions, Failure of the device’s intended purpose, and Injury or death.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate these products where available. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying these products. Any remaining stock should be quarantined immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) in order to ensure the removal of these unregistered products.
Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these products.

-Procurement staff in healthcare settings must obtain the registration status of medical devices falling in schedules D and E of the Medical Device Rules, 2017, from the suppliers. It’s imperative to note that authorized manufacturers and importers hold the exclusive right to provide medical devices in the market.

-Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersConsumers should stop using this product and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

Recall Alert: Medical Devices; Disposable Infusion Set by M/s Rehman Rainbow (Pvt), Lahore

Recall Alert

DRAP Alert NoNo I/07-23-28
Action Date27th July, 2023
Target Audience· Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses.
· Procurement Officers at Hospitals and Healthcare Institutions.
· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue Central Drugs Laboratory, Karachi received samples of Surgee Disposable Infusion Set manufactured by the M/s Rehman Rainbow (Pvt) Ltd , Industrial Estate, Kot Lakhpat, Lahore for testing. CDL has declared the sample as substandard based on the analysis for not complying the sterility criteria. Accordingly, the manufacturing company had been directed to recall all the defective product from the market.

Therapeutic Goods Affected:-

Product NamesProduct DescriptionBatch NoManufacturer
Surgee Disposable Infusion Set

Mfg Lic No 000510
Reg No 071602
Intravenous Infusion setBatch No IV0523
 
Mfg date 05.2023
 
Exp 04.2028
M/s Rehman Rainbow (Pvt) Ltd Lahore
 
Risk Statement:Use of Non sterile IV set poses a serious risk of patient harm and due to non-sterility can lead to bacteremia and sepsis.
Action Initiated-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.

-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsmsdra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these defective lots of the Medical Device.  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this Medical Device.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Recall Alert: Medical Devices; Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by Medtronic, USA

Recall Alert

DRAP Alert NoNo I/07-23-29
Action Date27th July, 2023
Target Audience• Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses.
• People implanted with affected ICDs and CRT-Ds.
• Procurement Officers at Hospitals and Healthcare Institutions.
• Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue Medtronic, USA received reports for their implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) for risk of patient harm as a result of low or no energy output when high voltage therapy is needed due to inappropriate activation of the Short Circuit Protection (SCP) feature. The issue is more likely to occur for devices with a glassed feedthrough that are configured to deliver therapy in the AX>B delivered pathway. Accordingly, the manufacturing company is recalling all the defective product from the international market including Pakistan.

Therapeutic Goods Affected:-

Brand NamesProduct DescriptionLot No and CodesManufacturer and Distributor
o Cobalt XT, Cobalt, Crome ICDs and CRT-Ds

o Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds

o Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs
Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)  are intended to monitor and regulate heart rate and rhythmMedical Device Recall Database Entries (FDA)
(click to open)


Distribution Dates: October 13, 2017 to June 9, 2023

Medtronic USA

Distributor in Pakistan:
M/s Medtronic Pakistan (Pvt) Ltd. Karachi.
 
Risk Statement:Defective ICDs, CRT-Ds poses a risk of patient harm as a result of low or no energy output when high voltage therapy is needed. Therefore, reduced-energy shock, or no shock at all, may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury, or death.
Action Initiated-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.

-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsmsdra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these defective lots of the Medical Device. Patient using the affected device should immediately contact their doctors for further guidance. Furthermore, Medtronic issued an Urgent Medical Device Correction notice to customers.

The communication provided the following required actions for software issue related to this recall: 

• Do not prophylactically replace devices for this issue.
• Program all high voltage therapy pathways B>AX in all therapy zones to minimize the risk of this issue.
• Prioritize reprogramming patients with a history of high voltage therapy and Rx1 programmed AX>B.
• Encourage patients with AX>B programming in any high voltage therapy sequence to attend their next scheduled follow-up in-clinic for device reprogramming.
• Remotely monitor patients following normal clinical protocol.


Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue:


1. Reduced- or no-energy high voltage therapy is displayed in Episode Text (regardless of programmed pathway)
2. A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy.


-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this Medical Device.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Rapid Alert; Drug Product: Falsified Sojourn ( Sevoflurane) Liquid For Inhalation

Rapid Alert

Falsified Sojourn ( Sevoflurane) Liquid For Inhalation

DRAP Alert NoNo  II/S/07-23-27
Action Date24th July 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
4. General Public
Problem StatementThe federal Inspector of Drugs, Quetta, took sample of suspected Sojourn liquid for inhalation from two different batches and sent it for analysis to the laboratory. The Central Drug Testing Laboratory, Karachi declared these samples as “Spurious” based on the analysis. The laboratory also identified the differences in the labeling and packaging of the falsified products in comparison to the authorized pack of registered products.

The product detail as under: –

Therapeutic Goods Affected:-

SrProduct NameBatch #Mfg. DateExp. DateManufactured by
(as stated on label)
Remarks
1Sojourn Liquid for Inhalation
 
Reg.No. 088891
S0502C11
S0512C14
Mar-22
Mar-27M/s Priamal Critical Care, Inc. USAThe sample is declared spurious for a non-complying identification test for Sevoflurane.  Instead, lab identified chloroform in the samples.
*The differences noted in the labeling and packaging of sample products declared as spurious in comparison to the authorized product from the marketing authorization holder are summarized in a table as Annexure-I.
Risk Statement:Sojourn (Sevoflurane) Liquid is an inhalational anesthetic agent which is indicated for use in the induction and maintenance of general anesthesia. It may lead to life-threatening reactions as the safety, quality, and efficacy of the product are unknown.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.

-Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.

Rapid Alert: Drug Product; Suspected increase in the availability of falsified versions of Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) in the markets.

Rapid Alert

Suspected Falsified GLP-1 Receptor Agonists

DRAP Alert NoNo  I/S/07-23-24
Action Date12th July 2023
Target Audience1. Regulatory Field Force
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics, etc.
3. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
4. Patients, Caregivers, and General Public.
Problem StatementGlucagon-like Peptide 1 Receptor Agonists (GLP-1-RA) are a class of Pharmaceuticals indicated to manage Diabetes type II. In Pakistan, only a single brand i.e. Ozempic injection manufactured by Novo Nordisk is registered by DRAP currently and is available as a “prescription only” product.

It is reported that there has been a surge of online information promoting the use of GLP-1 RA products for weight loss which is its unapproved use and this situation is encouraging risky procurement behaviors. Numerous online sources offer GLP-1 RA products for sale without requiring a prescription. The quality and safety of these medical products manufactured and distributed in poorly controlled environments (such as the internet) cannot be assured.

Due to the stated reasons, an increased demand resulting in a global shortage of these products has risen which may create environments favorable for the availability of falsified medical products. Reports have been received by WHO regarding an increase in the availability of falsified GLP-1-RA products in the past six months. It is possible that several versions of falsified GLP-1 RA – regardless of the brand name – are in circulation and available online.

Therapeutic Goods Affected:-GLP-1 receptor agonists
Products containing the following active ingredients:-
-semaglutide
-exenatide
-liraglutide
-dulaglutide
-lixisenatide
Threat to Public HealthFalsified medical products have been known to lack efficacy and/or cause toxic reactions. They are neither approved nor controlled by DRAP and may have been produced in unhygienic conditions by unqualified personnel, contain unknown impurities, and are sometimes contaminated with bacteria. It is also possible that people living with diabetes type II who miss treatment due to the unavailability of GLP-1-RA products may also suffer clinical consequences.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.

-Endocrinologists and Pharmacists present at healthcare facilities are requested to remain vigilant and inform patients of procuring medical products only from authorized channels.

-Adverse reactions or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersTo ensure authenticity, consumers should always obtain medical products from authorized licensed pharmacies /outlets. The authenticity of these products should be carefully checked and If the consumer has any doubt, advice must be sought from your pharmacist.

In case a consumer has experienced any problem related to taking or using these drug product(s), they should cease the use of the product in question immediately and contact their Physician or Pharmacist and should also report the incident to the Drug Regulatory Authority of Pakistan.

Rapid Alert; H&OTC Product: Falsified and Unregistered N-Gaisk Plus Tablets by M/s Naz Homoeo Pharmacy

Rapid Alert

Falsified and Unregistered N-Gaisk Plus Tablets

DRAP Alert NoNo  II/S/06-23-27
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
3. General Public
Problem StatementFederal Inspector of Drugs Karachi took the sample of N-Gaisk Plus Tablets and sent it to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Un-registered under the Drugs Act 1976

The product detail as under: –

Therapeutic Goods Affected:-

SrProduct NameBatch #Manufactured by Remarks
1N-Gaisk Plus Tablets
 
Registration No.: Nil

Mfg. Date: Aug 2022
Exp. date: Aug 2028
004M/s. Naz Homoeo Pharmacy, KarachiDiclofenac sodiumhas been identified on assay test (24.81mg) which is an allopathic drug and the sample is not registered with DRAP. Hence sample is declared as “Un-registered Drug Product”
Risk Statement:The Claimed Product is Homoeopathic with some quantity of an allopathic ingredient Diclofenac Sodium which is an Anti-Inflammatory/Rheumatic drug used to treat Rheumatoid Arthritis and associated pains. As the product is unregistered this infers that the quality and safety attributes of the product are not accepted and approved by DRAP.

Unregistered products containing Diclofenac Sodium may cause severe adverse reactions including Gastric bleeding and diarrhea.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.

-Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.

Rapid Alert; H&OTC Product: Falsified and Unregistered Sugar XL Capsules by M/s Naz Homoeo Pharmacy

Rapid Alert

Falsified and Unregistered Sugar XL Capsules

DRAP Alert NoNo  II/S/06-23-26
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
3. General Public
Problem StatementFederal Inspector of Drugs Karachi took the sample of Sugar XL capsules and sent it to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Unregistered under the Drugs Act 1976.

The product detail as under: –

Therapeutic Goods Affected:-

SrProduct NameBatch #Manufactured by Remarks
1Sugar XL Capsules
 
Registration No.: Nil

Mfg. Date: Nil
Exp. date: use within 5 years
NilM/s. Naz Homoeo Pharmacy, KarachiGlibenclamide has been identified on an assay test (3.34mg) which is an allopathic drug and the sample is not registered with DRAP. Hence the sample is declared as “Un-registered Drug Product.”
Risk Statement:The Claimed Product is Homoeopathic with some quantity of an allopathic ingredient Glibenclamide which is an oral hypoglycemic drug used to treat type 2 diabetes. As the product is unregistered this infers that the quality and safety attributes of the product are not accepted and approved by DRAP.
 
Unregistered products containing Glibenclamide may cause adverse reactions including variation in blood glucose level which may lead to hypoglycemic conditions and the patient may get faint.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.

-Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.

Rapid Alert: Drug Product; Falsified Defitelio Infusion  identified in the WHO Regions of Europe and the Eastern Mediterranean

Rapid Alert

WHO Medical Product Alert N°3/2023 On Falsified DEFITELIO (defibrotide sodium)

DRAP Alert NoNo  I/S/06-23-25
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics, etc.
3. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
4. Patients, Caregivers, and General Public.
Problem StatementWHO issued Medical Product Alert No. 3/2023 on falsified batch No. 19G19A, Expiry Date 01/2025, of DEFITELIO identified in the United Arab Emirates and publically reported by the national regulatory authority (in November 2022). The falsified batch was also identified in Kyrgyzstan (in March 2023). They have been identified in UK/Ireland packaging and US packaging. This falsified product is not registered in Pakistan.
The genuine manufacturer of DEFITELIO has confirmed that the products referenced in WHO alert are falsified. Lab analysis of a sample of falsified products found it did not contain any of the stated active ingredients. The genuine manufacturer has also advised that:
    i.  Stated batch number 19G19A is not a genuine DEFITELIO batch number
    ii.   Expiry dates are falsified
    iii.   Falsified US pack with batch 19G19A / Exp. 01/2025- the vial inside the pack has a different batch number- M06B466E which is not a genuine batch number.
Therapeutic Goods Affected:-DEFITELIO 80 mg/ml Concentrate for Infusion
Active Ingredient: (Defibrotide Sodium)
Registration No.: Nil
Batch No. Outer carton Batch: 19G19A Exp. date: 01/2025 and Inner vial Batch: M06B466E
Purported Manufacturer (as per label) M/s. Gentium SRl

For further information please click for details of the affected products.
Risk StatementDEFITELIO (Defibrotide sodium) is an antithrombotic agent used to treat severe venous-occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic (blood) stem cell transplantation.
·         Use of falsified products will compromise the treatment of disease and may intensify the existing condition.
·         It may lead to life-threatening reactions due to intravenous administration as safety, sterility and quality of product are unknown.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate the batch of products if available. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this batch product. The remaining stock should be quarantined immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) in order to ensure the removal of these products.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.

-Pharmacists and procurement officers present at healthcare facilities are requested to remain vigilant and inform patients of procuring medical products only from authorized channels.

-Adverse reactions or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersTo ensure authenticity, consumers should always obtain medical products from authorized licensed pharmacies /outlets. The authenticity of these products should be carefully checked and If the consumer has any doubt, advice must be sought from your pharmacist.

In case a consumer has experienced any problem related to taking or using these drug product(s), they should cease the use of the product in question immediately and contact their Physician or Pharmacist and should also report the incident to the Drug Regulatory Authority of Pakistan.

Rapid Alert; Drug Product: Falsified Ciproxin 500mg Tablets identified in the Market

Rapid Alert

Falsified Ciproxin 500mg Tablets

DRAP Alert NoNo  II/S/06-23-28
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores
3. General Public
Problem StatementProvincial Drug Control team has seized suspected falsified Ciproxin 500mg Tablets during the market surveillance activities in the District Kasur, Punjab. The Manufacturing Authorization holder company i.e. M/s Bayer Pakistan (Pvt) Ltd, Karachi has stated that based on the physical verification of security features, the products seized are not genuine, and thus it is a spurious/falsified products.

The product detail as mentioned on the label is as under: –

Therapeutic Goods Affected:-

SrProduct NameComposition as per labelBatch #Manufactured by (as stated on label)
1Ciproxin 500mg Tablets

Mfg.Date: 12-21
Exp.Date: 11-26
CiprofloxacinBAA928M/s.Novartis Pharma (Pakistan) Ltd, Karachi
For Bayer Pakistan (Pvt) Ltd, Lahore
Risk Statement:Consequences of use of Spurious/ Falsified Drugs includes but not limited to followings:
-Falsified/Spurious drugs may contain toxic and narcotic/psychotropic ingredients in unacceptable doses which may be life threating.
-These are manufactured under unhygienic condition without the proper inspection and approval, which are highly injurious to human health.
-Poor-quality medicines compromise the treatment of diseases and may intensified the existing condition.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products.

-Adverse reactions or quality problems experienced with the use of these product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.