Recall Alerts – Page 3 – Drug Regulatory Authority of Pakistan

Recall Alert: Drug Product; Dolor DS 100mg/5mL Suspension (Batch # 1236,1237 and 1238) by Adamjee Pharmaceutical, Karachi

Asad Ullah Recall Alerts December 6, 2023December 8, 2023

Recall Alert

DRAP Alert No	N^oII/S/10-23-42
Action Date	30th Nov, 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the03 Batches of product “Dolor DS Suspension” as of substandard quality. The detail of the affected product is as under:

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Dolor DS Suspension Reg.No 14451	Mefenamic Acid	Batch No1236, 1237, 1238 Mfg. Date: March 2023 Exp. Date: March 2025	M/s. Adamjee Pharmaceuticals (Pvt.) Ltd, Karachi

Risk Statement:	Mefenamic acid is used for the short-term relief of mild to moderate pain from various conditions such as headache, dental pain, menstrual cramps, and muscle aches. Inaccurate use of the product may lead to common side effects like skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. Impact of use of substandard product on basis of pH test may significantly altered the solubility and interfere with its absorption which may leads to sub optimal 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) has 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; Piperazine Elixer (Batch # L-085) by Swat Pharmaceuticals, Swat

Asad Ullah Recall Alerts November 24, 2023November 27, 2023

Recall Alert

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DRAP Alert No	N^oII/S/10-23-41
Action Date	20th Nov, 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the Batch No. L085 of product “Piperazine Elixer” as of substandard quality.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Piperazine 750mg/5ml Elixir Reg.No 002235	Piperazine Citrate	Batch No L-085 Mfg. Date: June 2023 Exp. Date: May 2025	Ms. Swat Pharmaceuticals, Saidu Sharif Swat.

Risk Statement:	Piperazine Citrate is used to treat common roundworms (ascariasis) and pinworms (enterobiasis; oxyuriasis). To avoid the common side effects of gastrointestinal disturbances, headache, dizziness, and urticaria, it is important to use the product accurately. It is critical to ensure that the product is not substandard, as its use can significantly alter the dose and lead to suboptimal therapeutic effects.
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) has 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: Recall of Liquid Preparations for Suspected Contamination of DEG/EG Impurities by M/s Pharmix Laboratories, Lahore

Asad Ullah Recall Alerts November 16, 2023November 16, 2023

Recall Alert

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DRAP Alert No	N^oI/S/11-23-40
Action Date	16th November 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	DRAP has issued a recall of certain batches of liquid preparations due to suspected contamination with diethylene glycol (DEG) and ethylene glycol (EG). WHO has also informed the suspected presence of DEG/EG impurities in batch No. B220 of Alergo Syrup, (identified in the Maldives) which was manufactured by M/s. Pharmix Laboratories (Pvt.) Ltd., Lahore. Following a preliminary investigation conducted by DRAP Lahore, it is suspected that these impurities may also be present in other batches and products mentioned below. This recall is a precautionary measure taken to safeguard public health against the potential harmful effects of these impurities

Therapeutic Good(s) Affected: –

Product Names	Batch No	Manufacturer
Mucorid Syrup	A230, C227, A211, A212, B201, L111, A210, A230, B224, L121, C210, B201, B225	M/s. Pharmix Laboratories (Pvt.) Ltd., 21-Km Ferozpur Road, Lahore.
Ulcofin Suspension	B209, C223	-do-
Alergo syrup	B220, L126	do-
Emidone Suspension	B227	do-
Zincell Syrup	C218	do-

Risk Statement:	Between 2022 and 2023, several countries reported incidents of oral liquid drugs that were intended for children and were found to be contaminated with high levels of DEG and EG. These incidents lead to severe adverse events and fatalities in few countries.
Action Initiated	-The manufacturing company has been directed to immediately recall the defective batches of the above-mentioned products from the market. All pharmacists and chemists working at distributions and pharmacies are hereby advised to immediately check their stocks and stop supplying these batches of suspected products. 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 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; Weena Syrup (Batch # L-090) by Swat Pharmaceuticals, Swat

Asad Ullah Recall Alerts November 14, 2023November 27, 2023

Recall Alert

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DRAP Alert No	N^oII/S/10-23-39
Action Date	6th Nov, 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the Batch No. L090 of product “Weena Syrup” as of substandard quality.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Weena Syrup Reg.No 003049	Ferrous sulfate and ascorbic acid	Batch No L-090 Mfg. Date: May 2023 Exp. Date: Apr 2025	Ms. Swat Pharmaceuticals, Saidu Sharif Swat.

Risk Statement:	Ferrous sulphate and ascorbic acid are used to treat and prevent iron deficiency anemia, as well as in prophylaxis for iron deficiency. Incorrect usage of the product can lead to common side effects, including various types of gastrointestinal distress such as nausea, diarrhea, vomiting, abdominal pain, constipation, and dark or discolored stool. The use of substandard products may significantly alter the dose, which can lead to suboptimal therapeutic effects.
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) has 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; Zolan 200mg/5ml Suspension (Batch # L-083) by Swat Pharmaceuticals, Swat

Asad Ullah Recall Alerts November 10, 2023November 13, 2023

Recall Alert

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DRAP Alert No	N^oII/S/10-23-35
Action Date	4th Oct, 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the Batch No. L083 of product “Zolan suspension” as of substandard quality.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Zolan 200mg/5mL Suspension Reg.No 027683	Metronidazole benzoate	Batch No L-083 Mfg. Date: May 2023 Exp. Date: Apr 2025	Ms. Swat Pharmaceuticals, Saidu Sharif Swat.

Risk Statement:	Metronidazole benzoate oral suspension is commonly used to treat bacterial infections and intestinal parasites. Inaccurate use of the product may lead to common side effects like nausea, vomiting, diarrhea, and abdominal discomfort; more severe reactions, such as convulsive seizures and peripheral neuropathy, may also occur. The impact of the use of substandard products on the basis of noncomplying pH may significantly alter the stability, and solubility of the product and may interfere with its absorption which could lead to sub-optimal 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) has 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; Kemodryl Cough Syrup (Batch # K-1068) by Alkemy Pharmaceutical (Pvt) Ltd., Hyderabad

Asad Ullah Recall Alerts October 26, 2023October 27, 2023

Recall Alert

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DRAP Alert No	N^oII/S/09-23-38
Action Date	16th Oct, 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the Batch No. L083 of product “Kemodryl Cough Syrup” as of substandard quality.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Kemodryl Cough Syrup Reg.No 007069	Chlorpheniramine Maleate 4mg: Ammonium Chloride 125mg : Sodium Citrate 55mg	Batch No K-1068 Mfg. Date: Aug 2023 Exp. Date: July 2025	Ms. Alkemy Pharmaceutical Laboratories (Pvt) Ltd., Hyderabad.

Risk Statement:	Kemodryl Cough Syrup is a combination of Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate which relieves cough. Chlorpheniramine is an anti-allergic which relieves allergy symptoms like runny nose, watery eyes and sneezing. Ammonium chloride can be used as an expectorant due to its irritative action on the bronchial mucosa. Sodium citrate is a mucolytic. Inaccurate use of the product may lead to common side effects like Stomach pain/epigastric pain, Allergic reaction, sleepiness, thickened respiratory tract secretions and impaired coordination. The impact of the use of substandard products on the basis of a higher limit of assay tests may cause adverse reactions on therapeutic doses.
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) has 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: Medical Devices; Trifecta Family of Valves by M/s ST. Jude Medical, USA

Asad Ullah Recall Alerts October 12, 2023October 12, 2023

Recall Alert

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DRAP Alert No	N^oII/S/09-23-37
Action Date	10th October, 2023
Target Audience	• Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Cardiologists, Pharmacists, and Nurses. • People implanted with affected Trifecta Family Valves. • Procurement Officers at Hospitals and Healthcare Institutions. • Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue	Abbot Structural Heart (St.Jude Medical, USA) has initiated a market withdrawal for the Trifecta family of valves (TrifectaTM Valve and TrifectaTM Valve with Glide Technology see table below) and will be removing the limited remaining inventory from the field due to potential for early Structural Valve Deterioration (SVD). Accordingly, the manufacturing company is recalling all the defective products from the international market including Pakistan. The Medical Device Board has already suspended the product registration in its 61^st Meeting and further course of action for deregistration is in process under the Medical Device Rules 2017.

Therapeutic Goods Affected:-

Brand Names and Description	Model No	GTN/UDI	Manufacturer and Distributor
TrifectaTM Valve 19mm TrifectaTM Valve 21mm TrifectaTM Valve 23mm TrifectaTM Valve 25mm TrifectaTM Valve 27mm TrifectaTM Valve 29mm TrifectaTM Valve with Glide Technology 19mm TrifectaTM Valve with Glide Technology 21mm TrifectaTM Valve with Glide Technology 23mm TrifectaTM Valve with Glide Technology 25mm TrifectaTM Valve with Glide Technology 27mm TrifectaTM Valve with Glide Technology 29mm	TF-19A TF-21A TF-23A TF-25A TF-27A TF-29A TFGT-19A TFGT-21A TFGT-23A TFGT-25A TFGT-27A TFGT-29A	05414734052016 05414734052023 05414734052030 05414734052047 05414734052054 05414734052061 05415067018205 05415067018212 05415067018229 05415067018236 05415067018243 05415067018250	M/s St. Jude Medical 11 county road b e saint paul, mn USA 55117 Distributor in Pakistan: M/s Verizon, 60-D, F.C.C Zahoor Elahi Road, Gulberg-IV, Lahore. Products registration no. MDIR -0003639. MDIR -0000233.

(Names and Models of defective products being recalled from market. For More Information please click here)

Risk Statement:	The valves are intended to maximize valve opening and improve hemodynamic performance. Therefore, defective trifecta family heart valves pose a risk of patient harm which will compromise the hemodynamic performance of the valve and can lead to cardiac arrest, other serious injuries.
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, Abbott, USA provided patient management considerations for those patients implanted with the Trifecta and Trifecta GT valves. https://www.structuralheart.abbott/fileadmin/pdf/FINAL_Abbott_Letter_US_Trifecta_Abbott_Website_sig ned.pdf) Understanding that clinical decisions are shared between healthcare providers and patients, please consider the following post-implant: · Patients should be reminded to seek medical attention with new onset of symptoms such as shortness of breath or fatigue. · An initial post-procedural transthoracic echocardiogram (TTE) study is recommended for all patients within 1 to 3 months after the implant procedure to evaluate valve hemodynamics and ventricular function. · Schedule annual follow-up visits beginning 1-year post-implant for clinical evaluation, including TTE to assess transvalvular gradients and valvular regurgitation grade. · Patients presenting with changes in symptoms (e.g., shortness of breath or fatigue on exertion) or signs (e.g., murmur) indicative of potential SVD should undergo a TTE. · Patients with evidence of hemodynamically significant SVD should be considered, in consultation with a heart team, for a possible valve intervention with either surgical aortic valve replacement (SAVR) or a trans catheter valve-in-valve intervention depending on individual patient risks and benefits. · Patients being considered for a valve-in-valve intervention should undergo pre-procedure planning with imaging studies to ensure all potential procedure-related risks such as coronary obstruction are minimized. Additional information regarding future valve-in-valve considerations can be found in the Trifecta GT valve IFU. Please note that the titanium frame of the Trifecta GT valve cannot be fractured using a balloon. Actions Abbott is Asking You to Take: · Please consider this information in your practice and share with relevant health care professionals (e.g., cardiac surgeons, cardiologists, primary care physicians) involved in the care of patients implanted with the Trifecta family of valves in your institution. · Complete and return the provided Acknowledgement Form. · Report any product incidents, regardless of procedure or patient outcome, to Abbott. -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 Model no and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to using this Medical Device and report the incident to National Pharmacovigilance Centre of Drug Regulatory Authority of Pakistan, through MedSafety Mobile Application, or online at Med Vigilance E Reporting System. -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; Albex 200mg Tablets (Batch#112) by M/s Swat Pharmaceuticals, Swat

Asad Ullah Recall Alerts October 10, 2023October 10, 2023

Recall Alert

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DRAP Alert No	N^oII/S/09-23-34
Action Date	22th 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
Albex 200mg Table Reg No. 020291	Albendazole 200mg	Batch No 112 Mfg date 04.2023 Exp date 03.2025	Ms. Swat Pharmaceutical, Swat.

Risk Statement:	Albendazole is an anthelminthic drug used to treat various parasitic worm infections. Substandard preparations of albendazole tablets may lead to treatment failure or suboptimal therapeutic effects, adverse effects, and increased antimicrobial resistance by exposing the parasitic worms to suboptimal concentrations of the drug.
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) has 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 Lipiodol Ultra Fluide 480mg/mL Injection

Asad Ullah Recall Alerts October 5, 2023October 5, 2023

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Rapid Alert

DRAP Alert No	N^oI/S/09-24-37
Action Date	October 05, 2023
Target Audience	1. Regulatory Field Force. 2. Healthcare Professionals – Physicians, Pharmacists, and Nurses. 3 Procurement officer at hospitals and institutions 4. General Public.
Problem Statement	The regulatory field force of DRAP and the Chief Drug Inspector Office, Karachi have identified a suspected falsified lot of Lipiodol Ultra Fluide 480mg/ml Injection which was intended to supply to tertiary care hospitals. The said product is not registered in Pakistan and is not imported using special permission pathways.
Threats to Public Health	The use of falsified or counterfeit Lipiodol injection can pose serious health risks as it may contain unknown ingredients or no active ingredient at all. This can lead to ineffective treatment, worsening of the condition, or unexpected side effects. In some cases, falsified products have been found to contain toxic materials which expose patients to harmful substances. The safety, sterility, and quality of the falsified products referenced in this alert are also unknown.

The product identification details are as under: –

Therapeutic Goods Affected:-

Product Name	Composition	Batch / Lot	Manufacture Name (as stated on label)	Remarks
Lipiodol Ultra Fluide 480mg/ml Solution for Injection (10ml) Registration No. Nil	Ethiodized-oil (radio-opaque contrast injection)	Batch No.: 15LU606A Exp. Date: 07-2024	Guerbet, 15 rue des Vanesses, Zone Paris Nord II France	The outer packaging, solution colour and consistency were different from the comparison to the original product.

Comparison of falsified Product against the original product by G.

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 at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by 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	Consumers should not use this product 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 Recall: Incidents of loss and damage of vision with the off-label use of Avastin 100mg/4ml injection

Yasir Mahmood Recall Alerts September 24, 2023November 15, 2023Alert, Patient Safety, SafetyAlert

Information Update on 3rd Nov, 2023: The recall of Avastin 100mg/4ml has been terminated based on the report of Central Drugs Laboratory, Karachi which declared the samples as of standard quality.

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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.

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.

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.