Product Recalls

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

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DRAP Alert No	No II/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

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DRAP Alert No	No II/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

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DRAP Alert No	No II/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

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Rapid Alert

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

DRAP Alert No	No  I/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

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

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DRAP Alert No	No I/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

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Rapid Alert

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

DRAP Alert No	No  I/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

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Rapid Alert

Unregistered Intravenous Medical Devices in the Market

DRAP Alert No	No  I/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:-

Sr	Product Name	Manufacturer/importer (as stated on label)	Illustration of unregistered medical devices
1	Euro Plus Infusion Set	Apex Medical Devices
2	Chiron Infusion Set	Not mentioned
3	Health Plus Infusion Set	Not mentioned
4	O’Divine Infusion Set	Not mentioned
5	Cath-Tec I.V Cannula	Nilhol Enterprises East Lane Business Park Wemby, UK
6	Healthflon I.V. Cannula	Healthylife 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 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

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DRAP Alert No	No I/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.

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

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

Recall Alert

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DRAP Alert No	No I/07-23-29
Action Date	27th 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 Names	Product Description	Lot No and Codes	Manufacturer 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 rhythm	Medical 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 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. 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

Asad Ullah Recall Alerts July 25, 2023July 26, 2023

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Rapid Alert

Falsified Sojourn ( Sevoflurane) Liquid For Inhalation

DRAP Alert No	No  II/S/07-23-27
Action Date	24th July 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 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:-

Sr	Product Name	Batch #	Mfg. Date	Exp. Date	Manufactured by (as stated on label)	Remarks
1	Sojourn Liquid for Inhalation   Reg.No. 088891	S0502C11 S0512C14	Mar-22	Mar-27	M/s Priamal Critical Care, Inc. USA	The sample is declared spurious for a non-complying identification test for Sevoflurane.  Instead, lab identified chloroform in the samples.

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 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.

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