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.

Recall Alert: Drug Product; Recall of Contaminated Liquid Preprations

Recall Alert

DRAP Alert NoNo I/S/01-24-05
Action Date30th January 2024
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 Government Analyst DTL Bahawalpur and DTL Rawalpindi have informed that following products are found to be of “sub-standard” quality due to presence of Ethylene Glycol (EG) impurity at unacceptable levels. Details of affected products is provided in table below.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No ManufacturerTest Results
Asthanil 60ml Syp
Ketotifen 1mg/5ml03-23M/s. Siza International (Pvt.) Ltd
18-Km Ferozpur Road, Lahore.
Ethylene Glycol: 2.896%
Does not comply
Virol Syrup
Ribavirin 5mg/5ml35080M/s. Raazee Therapeutics (Pvt.) Ltd.,
48-Km Lahore-Kasur Road, Lahore.
Ethylene Glycol: 3.31%
Does not comply
Torax DM Syrup
Dextromethorphan HBr 12.5mg & Diphenhydramine HCl 12.5mg110-23M/s. Siza International (Pvt.) Ltd.,
18-Km Ferozpur Road, Lahore.
Ethylene Glycol: 2.14%
Does not comply
Texcol EX Syrup
Acefylline Piperazine 45mg, Diphenhydramine HCl 8mg63833M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore.Ethylene Glycol: 0.985%
Does not comply
Texcol DM Syrup
Dextromethorphan HBr 10mg/5ml09953M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore.Ethylene Glycol: 1.19%
Does not comply
Allerphene Syrup
Chloepheniramine Maleate 2mg/5ml3002M/s. PDH Pharmaceuticals (Pvt.) Ltd., 19-Km Ferozpur Road, Lahore.Ethylene Glycol: 1.417%
Does not comply
Speczine Syrup
Promethazine HCl 5mg/5ml276M/s. Spectrum Laboratories (Pvt.) Ltd., 8-Km Raiwind Road, Lahore.Ethylene Glycol: 2.43%
Does not comply
Bronyl syrup


Nutraceutical cough preparationBL-013M/s. Florex Pharma Pvt Ltd, 25-Km Lahore-Jaranwala Road, Sheikhupura-Lahore.Ethylene Glycol: 0.12%
Does not comply
Action Initiated-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 also increase surveillance in the market to ensure the effective recall of defective products(s).

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at 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.

Warning To Therapeutic Goods Manufactures on DEG/EG Impurities in Raw Materials: A Serious Threat to Therapeutic Goods Quality and Safety

The Drug Regulatory Authority of Pakistan (DRAP) has issued a warning to the therapeutic goods industry about the use of raw material contaminated with diethylene glycol (DEG) and ethylene glycol (EG) impurities, which can pose serious health risks to consumers.

What is the issue?

The Central Drugs Laboratory Karachi has declared another sample of raw material i.e. propylene glycol (PG) as substandard sent for test/analysis due to unacceptable levels of ethylene glycol.

Propylene glycol, sorbitol and glycerin are used as solvents in the manufacturing of oral liquid preparations in the pharmaceutical and alternative medicines industry. When used in oral liquid preparations, these solvents can lead to serious health risks due to DEG and EG toxicity. When ingested, DEG and EG are metabolized into toxic metabolites that can affect the central nervous system, heart, and can cause kidney damage, which can be fatal.

In the past two years, there have been international reports related to the adulteration of these raw materials with DEG and EG causing kidney damage and death of children in Gambia, Uzbekistan, and Indonesia. Industrial grade DEG and EG are used for various applications (solvents, antifreeze agent) in other industries.

Earlier, several cases of substandard raw materials including PG and finished goods contaminated with DEG and EG have been reported from various part where investigations have suggested that the main problem lies with the integrity of supply chain of raw material which appears to be compromised. Consequently, action has been initiated against the culprits involved.

What are the actions taken by DRAP?

Despite repeated warnings and instructions, many therapeutic goods manufacturers have neglected to verify the quality and safety of their raw materials from authorized vendors. The Central Drug Laboratory, Karachi is currently analyzing both raw materials and finished products for EG and DEG contamination, following the pharmacopoeial standards and WHO guidelines for testing of EG and DEG in oral liquid preparations. To ensure the quality and safety of their products, manufacturers should test their raw materials for EG and DEG contamination before using them in their production processes to prohibit potential influx of contaminated products in the market.

In view of the criticality of the matter and potential for untold human tragedy, the therapeutic goods industry is once again warned to screen raw materials (propylene glycol, glycerin and sorbitol) for contamination with EG and DEG before using these materials in the manufacturing of oral liquid preparations. Additionally, all finished products must be analyzed for EG and DEG contamination before their release into the market. DRAP also issued directives to nutraceutical and alternative medicine companies to ensure compliance and safeguard public health from contaminated products. Additionally, the industry is diected to recall any finished products that were manufactured using the contaminated lot/batch of propylene glycol, hold the affected batches of finished products and ensure testing of finished products for EG and DEG contamination before releasing them into the supply chain.

DRAP urge pharma industry to take measures to prevent utilization of contaminated raw material in the manufacturing of liquid preparation including following:-

  • Implement a supplier qualification and verify the compliance of the suppliers with the relevant standards and regulations.
  • Verify traceability and authenticity of the raw material using unique identifiers such as barcodes or RFID tags to track their movement and origin throughout the supply chain.
  • Conduct regular risk assessments and monitor the performance of the suppliers, and take corrective actions if any issues are detected.
  • Educate and train the staff and the suppliers on the importance of preventing EG and DEG contamination, and the potential consequences of using contaminated solvents.
  • Verify the features that indicate the authenticity of the product, such as holograms, serial numbers, watermarks, or special packaging. The products should also be checked for any signs of poor printing, misspellings, inconsistent logos, tamper-evident seals or sturdy wrapping materials.

DRAP is committed to ensure the safety and quality of therapeutic goods in Pakistan, and protecting the public from substandard and falsified products.

Recall Alert: Drug Product; INCIP 200mg Infusion (Batch # CPV-85) by Inventor Pharma Pvt Ltd, Karachi

Recall Alert

DRAP Alert NoNo I/S/01-24-03
Action Date16th January, 2024
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. CPV-085 of product “INCIP Infusion” as of Substandard quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
INCIP 200mg Infusion
 
Reg.No 088363
CiprofloxacinBatch No. CPV-85
 
Mfg. Date: 09-23
Exp. Date: 09-25
M/s Inventor Pharma
(Pvt) Ltd, Karachi
Risk Statement:The impact of the use of substandard infusion on the basis of visible particulate matter may introduce contaminants into the bloodstream that lead to adverse reactions or sepsis.
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 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 (Batch #C815N3OR41) Allegedly Produced by Dow Chemical Thailand

Rapid Alert

DRAP Alert NoNo  I/S/01-24-02
Action Date11th January, 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementThe regulatory field force has identified a batch of Propylene Glycol (PG) that was used as a solvent in the manufacturing of oral liquid preparations. The batch was labelled as manufactured by Dow Chemical, Thailand. However, on analysis of a sample by the Central Drug Laboratory in Karachi, an unacceptable level of Ethylene Glycol was found..

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch No*Mfg DateExp. DateManufacturer
(as per label)
Remarks
Propylene Glycol
(Raw Material)
C815N3OR4103-2303-25Dow Chemicals, ThailandThe sample is declared substandard
for unacceptable levels of Ethylene Glycol (EG).

*Correction statement/corrigendum:
Verification of record/pictures shows that the identified batch number of contaminated propylene glycol was inadvertently written as C815N30R41 instead of C815N3OR41. Hence this batch number may be read as C815N3OR41.
Sincere apologies for the inconvenience this unanticipated ambiguity might have caused.

Dow Chemicals Thailand provided clarification to DRAP, stating that the identified samples were not their original product. Furthermore, the investigation revealed that their labels were false and that the samples were not manufactured by Dow Chemicals.

Risk StatementEthylene Glycol (EG) contaminated Propylene Glycol (PG) 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 taken possession of a 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. DRAP has directed the therapeutic industry to hold finished products manufactured from any other lot of propylene glycol of Dow Chemical Thailand 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:
 
_Recall Products: If any batch was manufactured using the same lot (C815N3OR41) of propylene glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.

Hold Other Batches: All finished products manufactured from any other lot of propylene glycol of Dow Chemical Thailand should be held. These products should be tested for EG/DEG contamination before releasing them into the supply chain.

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.

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

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

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.

Recall Alert: Drug Product; IS-NS (0.9%) Infusion (Batch # B6-24) by ISIS Pharmaceutical & Chemical Works, Karachi

Recall Alert

DRAP Alert NoNo I/S/12-23-48
Action Date2nd January, 2024
Target Audience·         Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses.
·         Procurement Officers at Hospitals and Healthcare Institutions.
·         Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue Federal Government Analyst, CDL Karachi has declared Batch No. B6-24 of product “IS-NS 0.9% INFUSION” as of Substandard quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
IS-NS 0.9% Infusion
 
Reg.No 104066
0.9% Sodium ChlorideBatch No. B6-24
 
Mfg. Date: 08-23
Exp. date: 08-25
M/s. ISIS Pharmaceutical
& Chemical Works, Karachi
Risk Statement:The use of substandard products based on assay tests may alter the dose and hamper the efficacy of the product leading to sub-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 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; Drug Product: Crackdown on Illegal Manufacturing and Seizure of Falsified Drugs

Rapid Alert

DRAP Alert NoNo  I/S/12-23-46
Action Date29th December, 2023
Target Audience1. Regulatory Field Force.
2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
3. Healthcare Professionals – Physicians, Pharmacists, and Nurses, Procurement officer at hospitals and institutions
4. General Public.
Problem StatementOn December 12, 2023, the regulatory field force in Karachi raided and shut down an illegal drug manufacturing facility. They collected product samples and sent them to the Central Drugs Laboratory (CDL) in Karachi for testing. The Federal Government Analyst at the CDL confirmed that the products seized by FID-III Karachi from the illicit site were “spurious”. The test results showed that these products lacked the stated active ingredients. There is a possibility that the fake manufacturers have infiltrated the supply chain with some of their falsified products.
Threats to Public HealthThe use of falsified products will result in ineffective treatment. This may cause therapy failure which may lead to increased morbidity and also, mortality, in case of untreated infections. Moreover, the safety of these falsified products is also unknown.

The product identification details are as under: –

Therapeutic Goods Affected*:-

Product NameComposition
(as per label)
Batch / LotMfg DateExp DateManufacture Name (as stated on label)Illustrative Images
AL Coxime 400mg
Capsule
Cefixime11004-2303-25M/s. Alpine Laboratories (Pvt) Ltd., KarachiSee DRAP Alert
Sinoxime 100mg/5ml
Dry Suspension
Cefixime101S1310-2309-25M/s. Alcons Laboratories Pvt Ltd., Karachi
Flox-G 500mg TabletLevofloxacin76001-2312-25M/s. Alcons Laboratories Pvt Ltd., Karachi
Flox-G 250mg TabletLevofloxacin76101-2312-25M/s. Alcons Laboratories Pvt Ltd., Karachi
Amcox 125mg/5ml
Suspension
Amoxicillin2321704-2303-25M/s. Alcons Laboratories Pvt Ltd., Karachi
Snagxone 1g injectionCeftriaxoneL23-406-2306-25M/s Leckman Laboratories Pvt Ltd., Karachi
Leckzolid 600mg TabletsLinezolid00209-24M/s Leckman Laboratories Karachi
Uniclav 156.25mg/5ml
Suspension
Co-amoxiclav12609-2308-25M/s. Uni-Tiech Pharmaceutical Pvt Ltd., Karachi
*The packaging of these products displays fake Drug Manufacturing Licenses (DML) and Drug Registration Numbers (DRN). None of these products are registered and no manufacturers with these names and addresses are licensed by DRAP.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate/seize these falsified products without any delay. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and halt the distribution/supply of these falsified products. Information related to the supplier of these falsified products should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of these falsified products.
Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these falsified products.

-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 these falsified products and should contact their physician or healthcare provider if they have experienced any problem related to taking or using any of these falsified products, and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

Recall Alert: Drug Product; Ketovet 100mg Injection (Veterinary use) (Batch # 2324108) by Vetz Pharmaceutical Pvt. Ltd, kotri

Recall Alert

DRAP Alert NoNo I/S/11-23-45
Action Date21st Dec, 2023
Target Audience• Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
• Veterinarians
• General Public
Problem / Issue Federal Government Analyst, CDL Karachi has informed DRAP regarding the sample of product namely “Ketovet injection” Batch No. 2324108 manufactured by M/s. Vetz Pharmaceuticals (Pvt.) Ltd., Plot #Q1, S.I.T.E Area, Kotri, Hyderabad has been declared as of “Substandard” quality

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Ketovet 100mg Injection
(Veterinary Use)

Reg.No 102014
KetoprofenBatch No. 2324108
 
Mfg. Date: 10-23
Exp. date: 09-25
M/s Vetz Pharmaceutical (Pvt) Ltd. Kotri
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 veterinary 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 Veterinary Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of veterinary pharmacies and facilities likely to be affected by this faulty batch.
Advice for Consumers-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; Espezar 20mg Tablets (Batch # A401) by Avant Pharmaceutical Pvt. Ltd, Hub, Baluchistan

Recall Alert

DRAP Alert NoNo I/S/11-23-44
Action Date21st Dec, 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 informed DRAP regarding the sample of product namely “Espezar tablet” Batch No. A401 manufactured by M/s. Avant Pharmaceuticals (Pvt.) Ltd., Plot No. 28 Hub Industrial Estate, Hub Balochistan has been declared as of “Substandard” quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Espezar 20mg Tablets
 
Reg.No 102983
EsomeprazoleBatch No. A401
 
Mfg. Date: 11-22
Exp. date: 11-24
M/s Avant Pharmaceutical
Pvt. Ltd, Hub, Baluchistan
Risk Statement:Esomeprazole is used to treat certain stomach and oesophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid the stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). Impact of use of substandard product may leads to sub optimal therapeutic effect which may cause therapy failure or other associated problems.
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 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; Sterile Water for Injection (Batch # B6-77) by ISIS Pharmaceutical & Chemical Works, Karachi

Recall Alert

DRAP Alert NoNo I/S/11-23-43
Action Date8th Dec, 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 informed DRAP regarding the sample of product namely “Sterile Water for Injection” Batch No. B6-77 manufactured by M/s. ISIS Pharmaceuticals & Chemical works, 25/1-4, Sector 12-C, North Karachi Industrial Area, Karachi, has been declared as of “Substandard” quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Sterile Water for Injection  
 
 
Reg.No 048819
Sterile Water for InjectionBatch No: B6-77
 
Mfg. Date: August 2023
Exp. Date: August 2025
M/s. ISIS Pharmaceutical
& Chemical Works, Karachi
Risk Statement:Sterile water for injection is a sterile, non-pyrogenic, and isotonic solution of water that does not contain any additives. It is mainly used as a solvent or diluent for other parenteral drugs, such as antibiotics and administered intravenously, intramuscularly, or subcutaneously.

Endotoxin is a toxic substance that can cause serious harm such as fever, inflammation, shock, coagulation, and immune suppression. Using endotoxin-contaminated water for injection can lead to life-threatening complications, especially if injected intravenously.
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 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.