Recall Alert: Recall of Adulterated Safemed Infusion Batch No. SJU-0824 Manufactured by M/s Ahad International Pharmaceuticals Ltd, Dera Ismail Khan

Recall Alert

DRAP Alert NoNo I/S/01-25-11
Action Date16th January 2025.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists
in Distribution, Pharmacies and Medical Stores
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue The Senior Drug Inspector, District Health Office, Quetta collected the samples of Infusion Safemed and sent them for test and analysis. The Provincial Drug Testing Laboratory, Quetta, has declared the following batch of Infusion Safemed, manufactured by M/s. Ahad International Pharmaceuticals Ltd., Sheikhupura, as Adulterated. The injection was found to contain foreign matter, which is visible to the naked eye:

Therapeutic Goods (s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Safemed 500mg Infusion
 
Reg. No. 045824
Metronidazole
Batch No.
SJU-0824
M/s. Ahad International Pharmaceuticals Ltd. 13-Km, Gomal University, Multan Road Dera Ismail Khan
Risk Statement:An injectable product that contains foreign matter is considered adulterated and may compromise the standard quality of the drug, as it may not be sterile. Sterility is a fundamental quality attribute for all injectable drugs. The presence of adulterated material can lead to serious adverse reactions in patients, including, but not limited to, the following:
(i) Anaphylactic shock, which can be fatal.
(ii) Skin rashes, itching, and difficulty in breathing.
(iii) Suboptimal or no therapeutic effect for the intended medical treatment.
Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.
– All pharmacists and chemists working at distributors 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 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 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.

Recall Alert: Substandard Product “Heparin-Indar Solution for Injection 5ml” Batch No. 64B0223B Mfg. By PRJSC <INDAR> Ukraine.

Recall Alert

DRAP Alert NoNo I/S/01-25-11
Action Date16th January 2025.
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 Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples of below product have been reported as substandard by Drug Testing Laboratory (DTL) Lahore:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Heparin-Indar solution for injection 5ml

(Heparin Sodium 2000IU/ml)Batch No.
64B0223B
PRJSC <Indar>, Ukraine, 02099, Kyiv, 5 Zeoshyvalna Str.
Risk Statement:The use of substandard injections 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 regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors 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 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 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.

Recall Alert: Substandard Product “Incip Infusion 100ml” Batch No. Cpv-147 Mfg. By Inventor Pharma (Pvt.) Ltd., Karachi.

Recall Alert

DRAP Alert NoNo I/S/01-25-10
Action Date16th January 2025.
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 Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples below product has been reported substandard by Drug Testing Laboratory (DTL) Lahore:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Incip Infusion 100ml
Ciprofloxacin (as lactate) 200mgBatch No.
CPV-147
Inventor Pharma (Pvt.) Ltd., Plot No. K/196, S.I.T.E. (SHW) PH-II, 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 regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors 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 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 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 Products

Rapid Alert

DRAP Alert NoNo  I/S/01-25-09
Action Date16th January, 2025
Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
3. General Public
Problem StatementDirectorate of Drugs Control (DDC) Punjab has informed DRAP that samples below product has been identified as spurious (falsified):

The product identification details are as under:

Therapeutic goods affected:

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)
Remarks
Duphaston tablet
(Dydrogesterone 10mg)
233493Purported to be manufactured by Highnoon Laboratories Ltd., LahoreSpurious
Depasrone tablet
(Dydrogesterone 10mg)
0363Purported to be manufactured by Alpine Laboratories, Karachi
(Fictitious firm)
Spurious

Risk Statement:The impact of the use of falsified 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 InitiatedThe field force under administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market.
Advice for Healthcare ProfessionalsAll 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) are advised to increase surveillance in the market to ensure the effective removal of this products.

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 at this link.
Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

Rapid Alert: CRACKDOWN AGAINST FALSIFIED PRODUCT

Rapid Alert

DRAP Alert NoNo  I/S/01-25-08
Action Date16th January, 2025
Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
3. General Public
Problem StatementDirectorate of Drugs Control (DDC) Punjab has informed DRAP that samples below product has been identified as spurious (falsified):

The product identification details are as under:

Therapeutic goods affected:

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)
Remarks
D-Gest tablet
(Dydrogesterone 10mg)
DGH003Purported to be manufactured by Mass Pharma (Pvt.) Ltd., LahoreSpurious

Risk Statement:The impact of the use of falsified 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 InitiatedThe field force under administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market.
Advice for Healthcare ProfessionalsAll 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) are advised to increase surveillance in the market to ensure the effective removal of this products.

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 at this link.
Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

Minutes of 343rd meeting of Registration Board held on 3rd- 5th December, 2024

The Drug Registration Board convened 343rd meeting on December 3 – 5, 2024, in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.

Rapid Alert: Presence of Counterfeit Ocrevus 300mg/10ml Solution for Injection Manufactured by Ms Roche Diagnostics GmbH, Mannheim, Almanya

Rapid Alert

DRAP Alert NoNo I/S/01-25-08
Action Date14th January, 2025
Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
·        General Public
Problem StatementTM/s Roche Pakistan Limited, Karachi, has notified DRAP, regarding the circulation of counterfeit Ocrevus 300mg/10ml Solution for Injection in the market across Pakistan. Investigation carried out by Roche Global revealed that the genuine product, batch H0041B27, was originally distributed to Turkey in August 2020 and expired on 07-02-2022, while the counterfeit sample displayed expiry date of 05-09-2025. These discrepancies confirmed the product as counterfeit. Details of counterfeit product are as follows:

S#Product NameCompositionBatch No.Manufactured by
(as per label claim)
Lab Test Results
1Ocrevus Solution for Injection, 300mg/10ml
 
(Ocrelizumab)H0041B27M/s Roche Diagnostics GmbH, Mannheim, Almanya.Counterfeit
Risk Statement:Ocrelizumab is a humanized monoclonal antibody used in the treatment of multiple sclerosis. The use of counterfeit productcould result in treatment failure, worsening of the disease, or life threatening consequences. 
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the mentioned product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product from the circulation.
Advice for Healthcare ProfessionalsDRAP 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 at this link.

Any adverse events or quality problems experienced with the use of these products should be reported to the 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 ConsumerConsumers 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.

Recall Alert: Recall of Adulterated Synostat Injection Batch No. Ss-0624 Manufactured by M/s Bajwa Pharmaceuticals Pvt. Ltd, Sheikhupura.Recall Alert:

Recall Alert

DRAP Alert NoNo I/S/01-25-07
Action Date13th January 2025.
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 Senior Drug Inspector, Quetta collected the samples of Synostat Injection and sent them for test and analysis. The Provincial Drug Testing Laboratory, Quetta, has declared following batch of Synostat Injection, manufactured by M/s. Bajwa Pharmaceuticals (Pvt.) Ltd., Sheikhupura, as Adulterated. The solution was found to contain foreign matter, which is visible through naked eye:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Injection Synostat

Reg. No. 098162
Tranexamic acidBatch No.
SS-0624
M/s. Bajwa Pharmaceuticals (Pvt.) Ltd. 36-Km, Lahore – Gujranwala Road, Khori District, Sheikhupura
Risk Statement:An injectable product that contains foreign matter is considered adulterated and may compromise the standard quality of the drug, as it may not be sterile. Sterility is a fundamental quality attribute for all injectable drugs. The presence of such adulterated material can lead to serious adverse reactions in patients or users, including, but not limited to, the following:
(i) Anaphylactic shock, which can be fatal.
(ii) Skin rashes, itching, and difficulty in breathing.
(iii) Suboptimal or no therapeutic effect of the intended medical treatment.
Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors 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 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 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 PRODUCT

Rapid Alert

DRAP Alert NoNo  I/S/01-25-05
Action Date10th January, 2025
Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
3. General Public
Problem StatementDirectorate of Drugs Control (DDC) Punjab has informed DRAP that samples below product has been identified as spurious (falsified):

The product identification details are as under:

Therapeutic goods affected:

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)
Remarks
Ketamine Injection
(Ketamine 500mg)
20158Purported to be manufactured by Pan Pharma, France.Spurious

Risk Statement:The impact of the use of falsified 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 InitiatedThe field force under administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market.
Advice for Healthcare ProfessionalsAll 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) are advised to increase surveillance in the market to ensure the effective removal of this products.

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 at this link.
Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

Recall Alert: Substandard Product “Sterile Water for Injection 5ml” Batch No. 224 Mfg. By M/s Pharmedic Laboratories (Pvt.) Ltd., Lahore

Recall Alert

DRAP Alert NoNo I/S/01-25-06
Action Date05th January 2025.
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 Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples below product has been reported substandard by Drug Testing Laboratory (DTL) Lahore:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Sterile Water for Injection, 5mlSterile Water for Injection,Batch no. 224
Pharmedic Laboratories, Lahore
Risk Statement:
The use of substandard injections 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 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 distributors 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 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 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.