Recall Alerts – Drug Regulatory Authority of Pakistan

Recall Alert: Recall of Nabaxo 10mg Film Coated Tablet Manufactured By M/s. Wenovo Pharmaceuticals, Taxila

Asad Ullah Recall Alerts November 15, 2024November 15, 2024

Recall Alert

DRAP Alert No	N^oI/S/11-24-48
Action Date	15^th November, 2024.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public
Problem / Issue	Senior Drug Inspector Islamabad has informed DRAP that batch number 263 of product namely Nabaxo 10mg film coated tablet has been declared as out of specifications by Drug Testing Laboratory Rawalpindi. Details of test reports are as under:

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch Details	Manufactured by
Nabaxo 10mg film coated tablet (Reg. No. 087751)	Rivaroxaban	Batch No.263	M/s. Wenovo Pharmaceuticals, Plot No. 31, 32, Punjab Small Industrial Estate, Taxila.

Risk Statement:	Nabaxo tablet contains Rivaroxaban is an anticoagulant medication used to treat and prevent blood clots. Rivaroxaban is used to treat deep vein thrombosis (blood clot, usually in the leg) and pulmonary embolism (blood clot in the lung) in adults. Substandard Rivaroxaban may lead to therapy failure in patients..
Action Initiated	-The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –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 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 these 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: Crackdown Against Falsified/Illegal Products

Asad Ullah Recall Alerts November 8, 2024November 12, 2024

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Rapid Alert

DRAP Alert No	N^oI/S/11-24-44
Action Date	08^th November, 2024
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · General Public
Problem Statement	The Directorate of Drugs Control (DDC) Punjab has identified the following falsified products in the market. The samples of these products were also analyzed by provincial Drug Testing Laboratories in Punjab. The details of the identified products are as under:

S#	Product Name	Composition	Batch No.	Manufactured by (as per label claim)	Lab Test Results
1	Ativan 2mg Tablets Reg# 000084	Lorazepam	17C7019	Purported to be manufactured by Pfizer Pakistan Ltd, Karachi Pakistan	Spurious
2	Klozen 5 mL Eye Drops Reg# 040124	Tobramycin 0.3%, Dexamethasone 0.1%	134	Purported to be manufactured by Zinta Pharmaceutical Industry, Hayatabad, Peshawar	Spurious
3	S-Kyne 10mg Tablets Reg# Nil	Dydrogesterone	566	Purported to be manufactured by Weather Folds pharmaceuticals, Hattar	Spurious & Misbranded
4	Efaston 10mg Tablets Reg# 31067	Dydrogesterone	064835	Purported to be Manufactured by Lahore Chemical & Pharmaceutical Works (Pvt) Ltd. Lahore	Spurious
5	Dydowen 10mg Tablets Reg# 101507	Dydrogesterone	462	Purported to be Manufactured by Weather Folds Pharmaceuticals, Hattar	Spurious
6	Phenobar 30mg Tablets Reg# 018862	Phenobarbitone	QA030	Purported to be Manufactured by Star Laboratories (Pvt) Ltd (Human Healthcare Division) 23-KM Multan Road Lahore	Spurious
7	Duphaston 10mg Tablets Reg# 006654	Dydrogesterone	230672	Purported to be Manufactured by Highnoon Laboratories Ltd. Marketed by Abbot Laboratories (Pakistan) Ltd, Lahore	Spurious

Risk Statement:	The impact of the use of falsified / Substandard products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems.
Action Initiated	The field force under the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the mentioned batches from the market.
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available on this link. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link
Advice for Consumer	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.

Rapid Alert: Recall of 04 Batches of Drug Products from Market

Asad Ullah Recall Alerts November 8, 2024November 11, 2024

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Rapid Alert

DRAP Alert No	N^oI/S/11-24-45
Action Date	08^th November, 2024
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · Veterinary Healthcare Professionals · General Public
Problem Statement	Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples following products have been analyzed by the provincial DTLs in Punjab and have been declared as substandard due to reasons mentioned below. The detail of affected products is as under:

S#	Product Name	Composition	Batch No.	Manufactured by	Test Results
01	Nida Infusion 100ml Reg. No. 079630	Metronidazole 500mg/100ml	23E317	GMP Pharmaceuticals, 28-Km Sheikhupura Road, Lahore.	Substandard due to visible particles and Bacterial Endotoxin.
02	Metroin Infusion 100ml Reg. No. 071279	Metronidazole 500mg/100ml	MT24-055	Saturn Pharmaceuticals, 23-Km, thokar Raiwind Road, Lahore	Substandard due to presence of visible particles.
03	Tylosan 20 Injection 100ml Reg. No. 027416 (For vet use only)	Tylosin base 200mg/ml	TS-259	Sanna Laboratories, 1019-B, P.I.S.E., Sargodha road, Faisalabad.	Substandard due to presence of visible particles.
04	Melacam-10 injection 50ml Reg. No. 063542 (For vet use only)	Meloxicam 10mg/ml	23U-03	Medi-vet (Pvt) Ltd., 17-Km Sheikhupura road, Lahore	Substandard on the basis of visible particles and extractable volume.

Threat to Public Health	Administration of products containing visible solid particles and/or bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc. which may have fatal consequences.
Action Initiated	The manufacturing companies of these products have been directed to immediately recall the affected batches of their products from the market. The Regulatory Field Force of DRAP and Provincial Drug Control Administrations have been directed to conduct market surveys for monitoring the recall process to ensure effective removal of defective batches from the market. All Pharmacists and Chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should have increased surveillance in the market to ensure the effective recall of defective products(s).
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link
Advice for Consumer	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.

Recall Alert: Drug Products; Recall of 02 Substandard Batches Manufactured by M/s Gulf Pharmaceuticals from the Market

Asad Ullah Recall Alerts, Uncategorized November 8, 2024November 15, 2024

Recall Alert

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DRAP Alert No	N^oI/S/11-24-47
Action Date	08^th November, 2024.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public
Problem / Issue	Federal Government Analyst, CDL Karachi vide test report No. IP-9-24-000082 dated 15-10-2024 has declared the product namely Hi-Z syrup batch No. S1427 as of substandard quality. Details of CDL test report are as under:

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch Details	Manufactured by
Hi-Z syrup (Reg. no. 075129)	20mg Elemental Zinc/5ml	Batch No. S1427 Mfg Date: 07-2024 Exp Date: 06-20226	M/s. Gulf Pharmaceuticals, Islamabad
Ufen Oral Suspension (Reg. No. 090274)	100mg Ibuprofen/5ml	Batch No. S1451 Mfg Date: 08-2024 Exp Date: 07-20226	M/s. Gulf Pharmaceuticals, Islamabad

Risk Statement:	Elemental Zinc syrups are used for reduction of duration and severity of diarrhea in children who are undernourished. Moreover, in patients suffering from Wilson disease, taking zinc by mouth improves symptoms by blocking how much copper is absorbed and increases how much copper the body releases. Sub-standard Zinc preparations may lead to complications in above mentioned conditions. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce fever, pain, and inflammation. Altered pH of an oral preparation may lead to gastrointestinal irritability, decreased stability and altered absorption of the product. These factors can ultimately lead to the therapy failure.
Action Initiated	–The manufacturer has been directed to immediately recall the defective batches of products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of products. 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) also increased 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 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 these 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: Falsified Rhophylac 300mcg PFS, Human Anti-D Immunoglobulin Injection Identified in Market

Asad Ullah Recall Alerts November 7, 2024November 8, 2024

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Rapid Alert

DRAP Alert No	N^oI/S/11-24-42
Action Date	07^th November, 2024
Target Audience	· National Regulatory Field Force. · Distribution, Pharmacies and Medical Stores · Healthcare Professionals – Physician, Pharmacist, Nurses · Maternal and Child Health Centres
Problem Statement	M/s Hakimsons Impex (Private) Ltd, Karachi, has notified DRAP regarding the presence of falsified Rhophylac 300mcg PFS in the market across Pakistan and also referred to letter No. 438/PDI-ZR/PWR, received from Provincial Inspector, Peshawar for verification of the sample. The packaging of the product shows two different batch numbers while barcode scan displays another batch number.

Product name	Batch/Lot No.	Manufacturer Name (as per label)	Mfg. date	Exp. date
Rhophylac 300mcg PFS, Human Anti-D Immunoglobulin	P100547971 P100644011 Barcode Batch: P100585096	M/s CSL Behring AG, Wankdorfstrasse 10, CH-3000 Bern 22,Switzerland.	10-2023	09-2026

Threat to Public Health	The Anti-D immunoglobulin 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. Falsified Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the products are unknown
Action Initiated	The Regulatory Field Force has been directed to increase the surveillance activities in market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered product
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link
Advice for Consumer	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.

Voluntary Recall Alert: Drug Product; Neo-Pyrolate Injection (Batch # 105B24) Manufactured by M/s Brookes Pharma (Pvt.) Ltd, Karachi.

Asad Ullah Recall Alerts October 28, 2024November 12, 2024

Recall Alert

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DRAP Alert No	N^oI/S/11-24-46
Action Date	28th October 2024.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public
Problem / Issue	M/s. Brookes Pharma Private Limited, Karachi, has initiated a voluntary recall of voluntary recall of the following product through public notice. The details of the product are as below:

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch Details	Manufactured by
Neo-pyrolate Injection IV 1ml × 10’s	Glycopyrrolate + Neostigmine Methylsulphate	Batch No. 105B24 Mfg. date: 02-2024 Exp. date: 02-2026	M/s Brookes Pharma (Pvt.) Ltd, Karachi.

Risk Statement:	The use of substandard injection may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions.
Action Initiated	The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to conduct market surveillance for the detection of the presence and removal of the recalled batches from the market.
Advice for Healthcare Professionals	All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the mentioned product. The remaining stocks 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). -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 products bearing the affected batch number(s) and should contact 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 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; Famila 150mg Injection (Batch # 083) By Zafa Pharmaceutical Laboratories, Karachi

Asad Ullah Recall Alerts October 25, 2024November 1, 2024

Recall Alert

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DRAP Alert No	N^oI/S/10-24-41
Action Date	24th October 2024.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public
Problem / Issue	The Federal Inspector of Drugs, Karachi collected the samples of Famila 150mg Injection and sent for test / analysis. The Central Drugs Laboratory, Karachi has declared batch No. 083 of Famila Injection, manufactured by M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi, as a substandard product.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch Details	Manufactured by
Famila 150mg Injection Reg.No. 015615	Medroxyprogesterone acetate	Batch No. 083 Mfg Date: 02-2023 Exp Date: 02-2029	M/s. Zafa Pharmaceutical Laboratories, Karachi

Risk Statement:	To comply with the Sterility testing for injections is crucial to ensure that the product is free from viable microorganisms. The samples of above mentioned product have been reported substandard based on sterility. The use of the said medicine may lead to transmission of blood borne infections and serious adverse events..
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 products. 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) also increased 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 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 these 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: Contaminated Propylene Glycol (Batch# YF01230522)

Asad Ullah Recall Alerts October 25, 2024October 28, 2024

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Rapid Alert

DRAP Alert No	N^oI/S/10-24-38
Action Date	25th October, 2024
Target Audience	1. Regulatory Field Force. 2. Therapeutic Goods industry 3. Manufactures of Oral liquid preparations 4. Healthcare professionals
Problem Statement	The Federal Government Analyst at Central Drugs Laboratory (CDL) Karachi has identified a contaminated batch of Propylene Glycol which has been declared substandard vide Report No. RM-8-24-000486 dated 19-09-2024. Samples of this Propylene Glycol (Raw material) were sent to CDL Karachi by a licensed pharmaceutical manufacturer in compliance with DRAP advisory on solvent testing. The manufacturer has been stopped from using the contaminated material and its supply chain is under investigation.

The product identification details are as under: –

Therapeutic Good Affected:-

Product	Batch No*	Mfg Date	Exp. Date	Manufacturer Name (as per label)	Remarks
Mono Propylene Glycol (Raw Material)	YF01230522	22-May-2023	21-May-2025	M/s. Dongying Hi-Tech Spring Chemical Industry Co. Ltd., China. [The material found in the packaging with the label of this manufacturer, however product authenticity and supply chain integrity are under investigation and yet not confirmed.]	The sample is declared substandard due to conatmination of Ethylene Glycol.

Note: On February 13, 2024, DRAP issued a Rapid Alert regarding contaminated Propylene Glycol (Batch #1P03-202308194). The investigation revealed that a falsified product had been packaged and labelled as being manufactured by Dongying Hi-Tech Spring Chemical Industry Co., Ltd. in China. The manufacturer also provided Certificate of Analysis (CoAs) to DRAP showing that the original product was not contaminated and analysis of retained samples met all required specifications.

Risk Statement	Di-Ethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
Action Initiated	The manufacturer has been instructed to halt the consumption of the contaminated material, and an investigation into the supply chain is underway. The Regulatory Field Force has increased surveillance to identify the contaminated batch of Propylene Glycol in the market. DRAP has strictly prohibited manufacturers of therapeutic goods from using Propylene Glycol without testing for Ethylene Glycol (EG) and Diethylene Glycol (DEG) levels.
Advice for Therapeutic Goods Manufacturers	Manufacturers of therapeutic goods are required to follow these instructions: 1. Recall Products: If any batch was manufactured using the same lot of Propylene Glycol that has been identified as contaminated, all finished products from local and export markets should be recalled. 2. Hold Other Batches: All finished products manufactured from the same lot of propylene glycol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain. 3. Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG. 4. Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products. 5. Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products. Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres. -Adverse Drug Reactions (ADR) 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 stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately 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.

Rapid Alert: Unregistered and Falsified RBST Injection Confiscated

Asad Ullah Recall Alerts October 25, 2024November 1, 2024

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Rapid Alert

DRAP Alert No	N^oI/S/10-24-40
Action Date	24th October 2024
Target Audience	· National Regulatory Field Force. · Distribution, Pharmacies and Medical Stores · Healthcare Professionals – Veterinarians, Chemists · Farmers/Consumers
Problem Statement	Federal Inspector of Drugs, Karachi alongwith FIA conducted a raid at premises of M/s Bismillah Medical Store, District Malir, Karachi and the following unregistered products/Stock was seized from the premises as per Form-2 under Section 18(1) of Drugs Act, 1976.

Product name	Batch/Lot No.	Manufacturer Name (as per label)	Mfg. date	Exp. date
Boostin Injection (Recombinant Bovine Somatropin) Reg. No. Nil	BSS22100	M/s LG Chem, Korea.	30-05-2023	29-05-2026

Threat to Public Health	Recombinant Bovine Somatotropin hormone is banned in the country due to serious side effects on health of animals and impact on those consuming milk and meat of such animals. The product is also banned in Europe, Canada, Australia etc.
Action Initiated	The Regulatory Field Force has been directed to increase the surveillance activities in market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered product
Advice for Veterinarian	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link
Advice for Farmers/Consumer	Farmers/Consumers should not use this product. They shall contact their physician or healthcare provider(s) if the animal experienced any problem that may be related to using this product.

Recall Alert: Drug Products; Recall of 04 Substandard Batches from the Market

Asad Ullah Recall Alerts October 25, 2024October 28, 2024

Recall Alert

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DRAP Alert No	N^oI/S/10-24-39
Action Date	25^th October 2024.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	The Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples of the following products have been identified as contaminated with DEG/EG impurities based on analysis conducted by the Drug Testing Laboratories Punjab. The Details of affected product batches are tabulated below:-

Therapeutic Good(s) Affected: –

S#	Product Name	Composition	Batch No.	Manufactured by	Test Results
01	Zonid Suspension 120ml Reg# 022579	Metronidazole 200mg/5ml	Z266	M/s. Bloom Pharmaceuticals (Pvt.) Ltd., Hattar.	Contains Ethylene Glycol Above Permissible limits
02	Hedazol Suspension 60ml Reg# 046146	Metronidazole 200mg/5ml	7037	M/s. Heal Pharmaceuticals (Pvt.) Ltd., Peshawar.	-do-
03	Vometol Suspension 120ml Reg# 094719	Domperidone 5mg/5ml	1347	M/s. Roryan Pharmceutical Industries (Pvt.) Ltd., Peshawar.	-do-
04	Tritadin Syrup 60ml Reg# 096413	Loratadine 1mg/ml	005	M/s. Trillium Pharmaceuticals (Pvt.) Ltd., Faisalabad.	-do-

Action Initiated	–The manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned 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, by phone at +92 51 9255969, or by Email at gsms∂dra.gov.pk. -The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance 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 these products 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.

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