Recall Alerts – Drug Regulatory Authority of Pakistan

Rapid Alert: Drug Product Recall: Incidents of loss and damage of vision with the off-label use of Avastin 100mg/4ml injection

Yasir Mahmood Recall Alerts September 24, 2023September 25, 2023Alert, Patient Safety, SafetyAlert

Rapid Alert

DRAP Alert No	N^oI/S/09-24-36
Action Date	September 24, 2023
Target Audience	1. Ophthalmologists and Endocrinologists 2. Healthcare Professionals – Physicians, Pharmacists, and Nurses. 3. Regulatory Field Force. 4. General Public
Problem Statement	Incidents of loss of vision in diabetic patients have been reported following treatment with Altered/Dispensed/Diluted Avastin injection. This product is approved by the Drug Regulatory Authority of Pakistan (DRAP) to treat Colorectal and other metastatic carcinomas. The use of this drug product in diabetic retinopathy or other ophthalmic conditions is one of the off-label uses and is not approved by DRAP. The incident is linked with the alteration/dispensing/dilution and sale of Avastin 100mg/4mL Injection under unhygienic/non-sterile conditions illegally and without any Drug Sale/Dispensing License (DSL) from Provincial Health Authority by M/s Genius Advanced Pharmaceutical Services Lahore.
Threats to Public Health	Avastin is a registered drug of M/s. Roche Pharma in Pakistan and is available in strength of 100mg/4ml and 400mg/16ml preparations. This drug is indicated for the treatment of colorectal and other metastatic carcinomas as a VGRF (vascular endothelial growth factor) inhibitor. However, the use in diabetic retinopathy is an off-label use to block the growth of abnormal blood vessels in the eye. Since this drug was being dispensed/diluted/repacked in 1.25mg/0.05ml dose under unhygienic conditions and in an unapproved manner, therefore, its safety cannot be ascertained which may lead to damage and loss of vision in the patients.

The product identification details are as under: –

Therapeutic Goods Affected:-

Following is the detail of the alleged product:

Product Involved	Manufacturer
Inj. Avastin 1.25 mg/0.05ml Composition: Bevacizumab Registration No. Nil	Genius Advanced Pharmaceutical Services.

Un-registered Product

Following is the detail of DRAP approved product:

Product Name	Suspected Batch	Manufacturer/Importer
Avastin 100mg/4ml Injection Composition: Bevacizumab Registration No. 043004	H0352B11 B7266B20 B7266B07	M/s Roche Diagnostics, Germany Importer: M/s Roche Pharma, Karachi.

Registered Product

Action Initiated	The Regulatory field force raided the premises of M/s Genius Advanced Pharmaceutical Services, Lahore, involved in the repacking and dispensing of Avastin injection under unhygienic/non-sterile conditions. The premises have been sealed and legal proceedings have been initiated against the personnel involved. The Importer of the registered product has been directed to recall the suspected batches of Avastin 100mg injection from the marked immediately. The sale/distribution of registered Avastin Injection has been put on halt till verification of its quality through sampling and laboratory testing to safeguard public health. Healthcare Professionals, Pharmacists and Chemists have been directed to stop the distribution, dispensing and administration of this product immediately, and check their stocks and stop supplying this product. The remaining stocks should be quarantined and returned to the supplier/company.
Advice for Healthcare Professionals	-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities regarding the off-label use of this product. -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 Consumers	Patients should not use this product for any ophthalmic disease and should 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: Unregistered and Falsified Immune globulin Products (Hyp-Rho-D and RhoColne Injections)

Asad Ullah Recall Alerts September 23, 2023September 23, 2023

Rapid Alert

DRAP Alert No	N^oI/S/09-23-35
Action Date	September 22, 2023
Target Audience	1. 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 Statement	The Regulatory field force has Identified two spurious brands of Anti-D immunoglobulin injections in the market which are not legally imported into Pakistan. The identified brands include Hyp-Rho-D purported to be manufactured by M/s. Woolmar Chemical Corporation USA and distributed by M/s. Zaryab Traders Lahore, and Rhocolone® 300 mcg purported to be manufactured by M/s. Bharat Serums and Vaccines Limited, India. The manufacturer and stated distributor of Hyp-Rho-D injection is unknown and has no legal status in the supply chain of drugs. Secondly, the authorized distributor of M/s. Bharat Serums and Vaccines Limited India i.e. M/s. Hakimsons (impex) (Private) Ltd., Karachi have informed us that their principal company has not supplied any batch of product Rhocolne 300mcg to Pakistan.

The product details are as under: –

Therapeutic Goods Affected:-

Sr	Product Name	Composition	Batch #	Mfg. Date	Exp. Date	Manufactured by (as stated on the label)
1	Hyp-Rho-D Injection Registration No: Nil	Rho (D) immunoglobulin (Human) for injection	09181943	—	Jan-2025	M/s. Woolmar Chemical Corporation, USA. Importer / Distributor: Ms. Zaryab Traders Lahore.
2	Rhocolne 300mcg Injection Registration No: Nil	Rho (D) immunoglobulin (Human) for injection	39VAN0065	05.11.2022	05.11.2022	Bharat Serums & Vaccines Limited, India.

Fig.1. Images of Falsified Hyp-Rho D Injection

Fig. 2. Images of Falsified Rhoclone Injection

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. Both of these products are 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 Initiated	The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate these products. 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 products. -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 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 these 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.

Recall Alert: Drug Product; Pedolil 250mg/5mL Suspension (Batch # 167) by M/S. JASM Pharmaceutical (Pvt.) Ltd., Risalpur.

Asad Ullah Recall Alerts September 22, 2023September 22, 2023

Recall Alert

DRAP Alert No	N^oII/S/08-23-32
Action Date	18th Sep, 2023
Target Audience	· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses. · Procurement Officers at Hospitals and Healthcare Institutions. · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Pedolil 250mg/5mL Suspension Reg No. 110389	Paracetamol (Acetaminophen)	Batch No 167 Mfg. date 05.2023 Exp. date 04.2025	Ms. JASM Pharmaceutical (Pvt.) Ltd., Risalpur

Risk Statement:	Paracetamol suspension is used for mild to moderate pain and fever. Inaccurate use of the product may lead to adverse reactions including but not limited to following: · Blood disorders, such as thrombocytopenia and leukopenia. · Liver and kidney damage. Impact of use of substandard product on basis of deliverable volume may leads to non- uniformity of dose and may alter therapeutic effect.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The 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). -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 gsms∂dra.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 Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 product. -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: Drug Product; Comycetin 0.5% Eye Drops (Batch # CYF003) by M/S. Nabiqasim Industries (Pvt) Ltd., Karachi

Asad Ullah Recall Alerts September 21, 2023September 21, 2023

Recall Alert

DRAP Alert No	N^oII/S/08-23-33
Action Date	18th Sep, 2023
Target Audience	· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses. · Procurement Officers at Hospitals and Healthcare Institutions. · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Comycetin 0.5% Eye Drop Reg No. 003682	Chloramphenicol	Batch No CYF003 Mfg date 02.2023 Exp date 02.2025	Ms. Nabiqasim Industries (Pvt.) Ltd., Karachi

Risk Statement:	Chloramphenicol is used to treat bacterial eye infections. The impact of use of the substandard product may lead to sub-optimal to no therapeutic effect and may intensify/flare the existing bacterial infection along with the development of Bacterial resistance.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The 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). -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 gsms∂dra.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 Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 product. -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: Drug Product; Kemygyl 200mg/5mL oral Suspension (Batch # M-319) by M/s. Alkemy Pharmaceutical Laboratories (Pvt) Ltd, Hyderabad

Asad Ullah Recall Alerts September 14, 2023September 14, 2023

Recall Alert

DRAP Alert No	N^oII/S/08-23-31
Action Date	08th Sep, 2023
Target Audience	· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses. · Procurement Officers at Hospitals and Healthcare Institutions. · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue	The Provincial Government Analyst/Director, Drug Testing Laboratory, Karachi has declared the Batch No. M-319 of Kemygyl Suspension as of substandard quality sampled by Provincial Inspector of Drugs Jamshoro.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Kemygyl Suspension 200mg/5ml	Metronidazole	Batch No M-3019 Mfg date 09.2022 Exp date 08.2024	Ms. Alkemy Pharmaceutical Laboratories (Pvt.) Ltd, Hyderabad.

Risk Statement:	Metronidazole Oral Suspension is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or suspected. Use of substandard products may lead to suboptimal to no-therapeutic effects and may contribute to drug resistance, and can also intensify/exacerbate the existing bacterial infection.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The 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). -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 gsms∂dra.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 Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 product. -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 Defitelio 80mg/mL Injection identified in Neighboring Countries

Asad Ullah Recall Alerts September 12, 2023September 12, 2023

Rapid Alert

Falsified Defitelio 80mg/mL Injection
(Updated form WHO)

DRAP Alert No	N^oI/S/09-23-44
Action Date	September 08, 2023
Target Audience	1. Regulatory Field Force. 2. Healthcare Professionals – Physicians, Pharmacists, and Nurses. 3. General Public.
Problem Statement	WHO has informed regarding the presence of a falsified batch of DEFITELIO (defibrotide sodium) Lot No. 20G20A detected in India (April 2023) and Türkiye (July 2023) and was supplied outside of regulated and authorized channels. This product is not registered in Pakistan however, due to its detection in the neighboring countries, it is highly likely that this product can infiltrate the Pakistani market. DEFITELIO (defibrotide) is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in hematopoietic stem-cell transplantation (HSCT) therapy. It is indicated for adults, adolescents, children and infants over 1 month of age. VOD is a condition in which the veins in the liver become blocked and stops the liver from working correctly. The genuine manufacturer of DEFITELIO has confirmed that the product referenced in this Alert is falsified. The genuine manufacturer has advised that: · Genuine DEFITELIO with Lot 20G20A was packaged in German/Austrian packaging. · The falsified products instead are in UK/Ireland packaging. · The stated expiry date is falsified and does not comply with the registered shelf life. · The stated serial number is not associated with batch 20G20A. · DEFITELIO does not have marketing authorization in India and Türkiye.

Therapeutic Goods Affected:-

Sr	Product Name	Composition	Batch/Lot #	Mfg. Date	Exp. Date	Manufactured by (as stated on label)
1	DEFITELIO 80 mg/mL concentrate for solution for infusion	Defibrotide	20G20A	—	Aug-2024	Gentium Srl (UK/ Ireland packaging)

Threats to Public Health	The use of falsified DEFITELIO will result in the ineffective treatment of patients and may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances. Moreover, the safety, sterility, and quality of the falsified products referenced in this alert are also unknown.
Action Initiated	The Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. Since this product is not registered with DRAP, it is not permitted to be stocked or sold in pharmacies or other retail outlets. However, it is crucial for all healthcare professionals, including pharmacists and chemists, to check their stock immediately and stop the distribution or supply of this product if it is found. Information related to the supplier of this product 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 Consumers	Consumers 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.

Pictures of Defiiteli 80mg/mL injection identified as falsified Product

Pictures of Falsified Defitelio 80mg/mL Injection identified in Türkiye

Recall Alert: Drug Product; Plivil 25mg Injection (Batch # 847) by M/s. Pliva Pakistan, (Pvt) Ltd, Baluchistan

Asad Ullah Recall Alerts September 7, 2023September 7, 2023

Recall Alert

DRAP Alert No	N^oI/S/08-23-22
Action Date	06th Sep, 2023
Target Audience	· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses. · Procurement Officers at Hospitals and Healthcare Institutions. · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue	The Secretary, PQCB Baluchistan has informed DRAP that samples of Plivil Injection (Batch No. 847) manufactured by M/s. Pliva Pakistan (Pvt.) Ltd., B-77, Lasbella Industrial Estate, Baluchistan, has been analyzed by the Government Analyst, Drug Testing Laboratory (DTL), Baluchistan, Quetta and declared as Adulterated and misbranded based on analysis.

Therapeutic Goods Affected:-

Product Names	Composition	Batch No	Manufacturer
Plivil 25mg/ml Injection Reg No 021513	Pheniramine Maleate 25mg/ml	Batch No 847 Mfg date 02.2023 Exp date 02.2025	M/s. Pliva Pakistan (Pvt.) Ltd., Baluchistan.

Risk Statement:	Presence of foreign particles may interact within the injectable solution and may change the chemical consistency of the solution. If injected, they can cause inflammation, tissue damage, or allergic or immunogenic reactions. Additionally, unclear labels on the drug products may create difficulty in reading and understanding of drugs and may lead to medication errors such as taking the wrong medication or the wrong dose.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The 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). -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 gsms∂dra.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 Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 product. -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: Unregistered and Falsified Hyp-Rho-D injection (Rho(D) immune globulin Injection

Asad Ullah Recall Alerts August 15, 2023August 17, 2023

Rapid Alert

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

DRAP Alert No	N^oI/S/08-23-30
Action Date	August 02, 2023
Target Audience	1. 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 Statement	The 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:-

Sr	Product Name	Composition	Batch #	Mfg. Date	Exp. Date	Manufactured by (as stated on label)	Remarks
1	Hyp-Rho-D Injection Registration No: Nil	Rho (D) immunoglobulin (Human) for injection	09181943	—	Aug-2024	M/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 Initiated	The 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 Consumers	Consumers 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

Asad Ullah Recall Alerts August 11, 2023August 12, 2023DRAP, Drugs, Medical Devices, QA & LT, QualityDefects, RapidAlert

Rapid Alert

Unregistered Intravenous Medical Devices in the Market

DRAP Alert No	N^oI/S/08-23-31
Action Date	10th August 2023
Target Audience	1. 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 Statement	The 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:-

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 Initiated	The 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 Consumers	Consumers 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

Asad Ullah Recall Alerts July 31, 2023August 3, 2023

Recall Alert

DRAP Alert No	N^oI/07-23-28
Action Date	27th 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 Names	Product Description	Batch No	Manufacturer
Surgee Disposable Infusion Set Mfg Lic No 000510 Reg No 071602	Intravenous Infusion set	Batch 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 gsms∂dra.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 Professionals	DRAP 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.

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