Recall Alert: Drug Product; Barpon 100mg/5mL Suspension (Batch # 202) by M/s. JASM Pharmaceutical, KPK

Recall Alert

DRAP Alert NoNo II/S/03-24-13
Action Date13th March 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 etc.
Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. KQ-11-23-000155 dated 12-12-2023 has declared the subject mentioned product namely Barpon 100mg/5mL (Batch No. 202) as of substandard quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Barpon 100mg/5mL Suspension
 
Reg No.114785
IbuprofenBatch No.  202
 
Mfg Dt: 07-2023
Exp.Dt: 06-2025
M/s. JASM Pharmaceutical
(Pvt.) Ltd., Risalpur.
Risk Statement:Barpon Infusion contains Ibuprofen, a medicine used to treat mild to moderate pain and fever (high temperature). Administration of substandard products may lead to complications, as well as an increased risk of failure of therapy. The age-profile of patients is important and young patients especially are at risk.
Action Initiated-The manufacturer has been directed to immediately recall the defective batch of above mentioned product from the market. All pharmacists and chemists working at distributions and pharmacies are hereby advised to 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 DRAP and Provincial Health Departments are also informed regarding the matter and are directed to 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 gsmsdra.gov.pk.

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

Rapid Alert

DRAP Alert NoNo  II/S/03-24-14
Action Date8th March 2024
Target Audience1.Therapeutic Goods industry
2. Manufactures of Oral liquid preparations
Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis vide No. RM-2-24-000179 and No. RM-2-24-000180 dated 01-03-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by Federal Inspector of Drugs Islamabad-I as of substandard quality due to contamination of DEG and EG. ( Click for details)

Two samples were collected from separate containers which were labelled as Propylene Glycol, Batch# C815L44R41 and Batch# C815L44R52, purportedly manufactured by Dow Chemical Pacific (Singapore) Private Limited. However, upon further investigation, it seems that none of the samples were actually manufactured by Dow Chemicals and the labels were false.

It is important to note that on January 11, 2024, a rapid alert was also issued for contaminated Propylene Glycol with batch number C815N3OR41, which was labelled as being manufactured by Dow Chemicals, Thailand. However, Dow Chemicals, Thailand has clarified to DRAP that it was not their original product and was falsified by some miscreants. The company also analyzed the retained samples of the original product and shared an analysis report, which showed that it was in compliance with the required specifications.
Risk Statement:Diethylene glycol (DEG) and Ethylene Glycol (EG) contamination in Propylene Glycol (PG) can lead to serious health risks when used in oral liquid preparations. Upon ingestion, these chemicals (EG and DEG) are converted into toxic metabolites which can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
Action Initiated: –The Regulatory Field Force has taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1.      Recall Products: If any batch of finished product has been manufactured using the same batch of the propylene glycol that has been identified as contaminated, the retained sample should be immediately analysed and these finished products should be recalled from local and export markets if found contaminated.


2       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.

3.     Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

4.    Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

5.     Follow Guidelines: Adhere to the pharmacopeial 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 ProfessionalsDRAP 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 ConsumersConsumers 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: Substandard Propylene Glycol (Batch # G01821UG) claimed to be manufactured by SK Picoglobal Korea.

Rapid Alert

DRAP Alert NoNo  I/S/03-24-12
Action Date8th March 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementMs. MKB Pharmaceuticals (Pvt) Ltd., Peshawar sent the sample of Propylene Glycol (PG) to Central Drugs Laboratory Karachi for test/analysis that was used as a solvent in the manufacturing of oral liquid preparations. The batch was claimed to be manufactured by SK picoglobal Co. Ltd. Korea. Analysis of the sample by the Central Drug Laboratory, Karachi detected unacceptable level of Ethylene Glycol.

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoMfg DateExp. DatePurported to be Manufactured by
(as per label)
Remarks
Propylene Glycol
(Raw Material)
G01821UG12-08-202311-08-2025SK Picoglobal Co. Ltd. Korea.The sample is declared substandard
for unacceptable levels of Ethylene Glycol (0.4671%).
Risk StatementPropylene Glycol (PG) contaminated with Ethylene Glycol (EG) when used in oral liquid preparations, can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal.
Action InitiatedThe manufacturer has been instructed to recall finished products that were manufactured using the contaminated lot of propylene glycol. The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market. DRAP has directed the therapeutic goods industry to hold finished products manufactured from any other lot of propylene glycol of Ms. SK picoglobal Co. Ltd. Korea and ensure testing of finished products for EG/DEG contamination before releasing them into the supply chain.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1.      Recall Products: If any batch was manufactured using the same lot (YF01200730) 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 any other lot of propylene glycol of SK picoglobal Co. Ltd. Korea should be held. 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.      Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

5.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

6.      Follow Guidelines: Adhere to the pharmacopeial 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 ProfessionalsDRAP 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 ConsumersConsumers 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: Contaminated Propylene Glycol Identified and Confiscated

Rapid Alert

DRAP Alert NoNo I/S/02-24-11
Action Date07th March 2024
Target Audience1. Therapeutic Goods industry
2. Manufactures of Oral liquid preparations
Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi has identified contaminated Propylene Glycol (Raw material) by detecting highly unacceptable levels of Ethylene Glycol in the seven different samples of Propylene Glycol which were sent to the laboratory by the Federal Inspector of Drugs Lahore. 

Out of the seven samples collected from different containers, six of them had labels indicating that they were from Batch#C856H85R55 and were labelled as manufactured by Dow Chemicals, Thailand. However, one of them (sample 7) had a label indicating that it was from batch F8900L8PPD6 and was labelled as manufactured by Dow Chemicals, Germany. Upon further investigation, it seems that none of the samples were actually manufactured by Dow Chemicals and the labels were false. The analysis reveals that these samples were highly contaminated.

It is important to note that on January 11, 2024, a rapid alert was also issued for contaminated Propylene Glycol with batch number C815N3OR41, which was labelled as being manufactured by Dow Chemicals, Thailand. However, Dow Chemicals, Thailand has clarified to DRAP that it was not their original product and was falsified by some miscreants. The company also analyzed the retained samples of the original product and shared an analysis report, which showed that it was in compliance with the required specifications.
Risk StatementDiethylene glycol (DEG) and Ethylene Glycol (EG) contamination in Propylene Glycol (PG) can lead to serious health risks when used in oral liquid preparations. Upon ingestion, these chemicals (EG and DEG) are converted into toxic metabolites which can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
Action TakenThe Regulatory Field Force has taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market.
Advice for Therapeutic Goods Manufacturers: – Manufacturers of therapeutic goods are required to follow these instructions:
 
1.      Recall Products: If any batches were produced using the same lots of Propylene Glycol that have been identified as contaminated, it is crucial to test both the raw materials and finished products for contamination immediately. If any contamination is found, the affected products should be recalled promptly from the local and export markets.

2.      Hold Other Batches: All finished products manufactured from propylene glycol 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 of 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.

DRAP’s 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.

Recall Alert: Drug Product; DXL 60mg Capsule (Batch # 23136) by M/s. Titlis Pharma Lahore

Recall Alert

DRAP Alert NoNo II/S/02-24-09
Action Date27th February, 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 etc.
Problem / Issue The Secretary, PQCB Baluchistan has reported that samples of “DXL 60mg Capsule” bearing Batch No. 23136 manufactured by M/s. M/s. Titlis Pharma, 528-A Sundar Industrial Estate, Raiwind Road, Lahore. has been declared as “Substandard” by Government Analyst, Drug Testing Laboratory, Baluchistan.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
DXL 60mg Capsule
 
Reg.No 097679
DexlansoprazoleBatch No.  2336
 
Mfg. Date: 03-23
Exp. date: 03-25
M/s. Titlis Pharma,
528-A Sundar Industrial Estate,
Raiwind Road, Lahore.
Risk Statement:The use of substandard dexlansoprazole capsules may lead to untoward adverse drug reactions and may generate an unpredictable response based on individual variability.
Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan 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 gsmsdra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by 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; Mencobal 500mcg Injection (Batch # 082) by M/s. Treat Pharmaceutical Industry (Pvt.) Ltd.,Bannu.

Recall Alert

DRAP Alert NoNo I/S/02-24-08
Action Date27th February, 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 etc.
Problem / Issue The Secretary, PQCB Baluchistan has reported that samples of Mencobal Injection bearing Batch No. 082 manufactured by M/s. Treat Pharmaceutical Industry (Pvt.) Ltd., Bannu, has been declared as “Substandard” by Government Analyst, Drug Testing Laboratory, Baluchistan.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Mencobal 500mcg Injection
 
Reg.No 075537
MecobalaminBatch No. 082
 
Mfg. Date: 06-23
Exp. date: 06-25
M/s. Treat Pharmaceutical Industry
(Pvt.) Ltd., A-37 Small Industrial Estate,
Township, Kohat Road, Bannu.
Risk Statement:The impact of the use of substandard injectable preparations can be serious as it may lead to infection and others adverse reactions or even sepsis.
Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan 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 gsmsdra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by 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; SN ZOR 200mg/5mL Suspension (Batch # 342) by M/s. S.N.B Pharma (Pvt) Ltd. Peshwar

Recall Alert

DRAP Alert NoNo II/S/02-24-10
Action Date26th February, 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 etc.
Problem / Issue The Federal Government Analyst, CDL Karachi has declared the Batch No. 342 of product “SN Zor 200mg/5mL suspension for oral use, manufactured by S.N.B Pharma (Pvt) Ltd. Peshawar as Substandard for non-complying assay result.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
SN Zor 200mg/5mL Suspension
 
Reg No. 074547
AzithromycinBatch No. 342

Mfg. Date: 08-23
Exp. date: 08-25
M/s. S.N.B Pharma
(Pvt) Ltd. Peshawar
Risk Statement:The impact of the use of substandard powder for oral suspension on the basis of low assay may cause sub-optimal effects and therapeutic failure.
Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan 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 gsmsdra.gov.pk.

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

Rapid Alert

DRAP Alert NoNo  I/S/02-24-07
Action Date16th Feb, 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementThe regulatory field force of Punjab has identified suspected samples of the following product in the market and sent them for analysis in the Drug Testing Laboratories. The Government Analyst has reported that these three products are falsified/spurious. The labelled stated manufacturer has informed that these samples are not manufactured and supplied by themselves in the market.

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoManufacturer
(as per label)
Duphaston 10mg Tablet
Dydrogesterone 10mg223298M/s. Highnoon Laboratories Ltd, 17-Km Multan Road, Lahore.
Femara 2.5mg TabletLetrozole 2.5mgTTT60M/s. Novartis Pharma Stein AG SCHAFFHAUSERSTRASSE
Oxidil 1g InjCeftriaxone 1g050KM/s Healthtek Pvt Ltd, Karachi
Threat to Public HealthThe use of these falsified products will result in the ineffective treatment of patients. Moreover, the safety and quality of the falsified products referenced in this alert are also unknown.
Action InitiatedThe 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. 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 to halt the distribution/supply of this product. Information related to the supplier of these product’s batches 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 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 ConsumersConsumers should not use products bearing these batches 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: Contaminated Propylne Glycol (Batch # 1P03-202308194) Allegedly Produced By M/s. Shinghwa Amperex Technology (Dongying), China.

Rapid Alert

DRAP Alert NoNo  I/S/02-24-06
Action Date13th Feb, 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. RM-1-24-000027 dated 31-01-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by M/s. Biolabs (Pvt.) Ltd., Islamabad in compliance to letter vide No. 03-41/2023-QC dated 01-12-2023. Details of test/analysis report are given as under:

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoMfg DateExp. DateManufacturer
(as per label)
Remarks
Propylene Glycol
(Raw Material)
1P03-20230819426-08-202325-08-2025M/s. Shinghwa Amperex Technology
(Dongying) Co. Ltd., China.
The sample is declared substandard
for unacceptable levels of
Ethylene Glycol (EG) and Diethylene Glycol.
Risk StatementDi-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 InitiatedThe Regulatory Field Force has directed to take necessary action on above mentioned contaminated batch of Propylene Glycol and is investigating the entire supply chain of this batch. The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of propylene glycol. The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1. Recall Products: If any batch was manufactured using the same lot (1P03-202308194) 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 any other lot of propylene glycol of M/s. Shinghwa Amperex Technology (Dongying) Co. Ltd., China 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.      Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

5.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

6.      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. Before their release into the market, all finished products should be analyzed for EG/DEG contamination.
Advice for Healthcare ProfessionalsDRAP 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 ConsumersConsumers 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: Contaminated Glycerin (Batch # 1A2192K) Allegedly Produced By M/S KLM Palm Oleo BHD, Malaysia

Rapid Alert

DRAP Alert NoNo  I/S/02-24-03
Action Date01stFeb, 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementMs. Cibex Private Limited Pharmaceuticals, Karachi sent the sample of Glycerin to Central Drugs Laboratory Karachi for test/analysis that was used as a solvent in the manufacturing of oral liquid preparations. The batch was labelled as manufactured by Ms. KLK PALM OLEO SDN BHD, Malaysia. However, on analysis of a sample by the Central Drug Laboratory in Karachi, an unacceptable level of Ethylene Glycol was found. The details of the affected batch are as under:-

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoMfg DateExp. DateManufacturer
(as per label)
Remarks
Glycerin
(Raw Material)
IA2192K06-10-2205-10-24KLK Palm Oleo SDN BHD,
Malaysia
The sample is declared substandard
for unacceptable levels (0.1662%) of
Ethylene Glycol (EG)..
Risk StatementGlycerin contaminated with Ethylene Glycol (EG) when used in oral liquid preparations can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal..
Action InitiatedThe Regulatory Field Force has directed to take necessary action on above mentioned contaminated batch of Glycerin and is investigating the entire supply chain of this batch. The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of Glycerin. DRAP has directed the therapeutic industry to ensure the testing of this lot or any other lot of raw material prior to use in manufacturing of finished products.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1. Recall Products: If any batch was manufactured using the same lot (1A2192K) of glycerin 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 any other lot of glycerin of Ms. KLK PALM OLEO SDN BHD, Malaysia should be held. 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.      Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

5.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

6.      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 ProfessionalsDRAP 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 ConsumersConsumers 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.