Rapid Alert: Unregistered and Falsified RBST Injection Confiscated

Rapid Alert

DRAP Alert NoNo I/S/10-24-40
Action Date24th October 2024
Target Audience·         National Regulatory Field Force.
·         Distribution, Pharmacies and Medical Stores
·         Healthcare Professionals – Veterinarians, Chemists
·         Farmers/Consumers 
Problem StatementFederal Inspector of Drugs, Karachi alongwith FIA conducted a raid at premises of M/s Bismillah Medical Store, District Malir, Karachi and the following unregistered products/Stock was seized from the premises as per Form-2 under Section 18(1) of Drugs Act, 1976.
Product nameBatch/Lot No.Manufacturer Name
(as per label)
Mfg. dateExp. date
Boostin Injection
(Recombinant Bovine Somatropin)

Reg. No. Nil
BSS22100M/s LG Chem, Korea.   30-05-202329-05-2026
Threat to Public HealthRecombinant Bovine Somatotropin hormone is banned in the country due to serious side effects on health of animals and impact on those consuming milk and meat of such animals. The product is also banned in Europe, Canada, Australia etc.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities in market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered product
Advice for VeterinarianDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link
Advice for Farmers/ConsumerFarmers/Consumers should not use this product. They shall contact their physician or healthcare provider(s) if the animal experienced any problem that may be related to using this product.

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 Products; Recall of 04 Substandard Batches from the Market

Recall Alert

DRAP Alert NoNo I/S/10-24-39
Action Date25th October 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue The Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples of the following products have been identified as contaminated with DEG/EG impurities based on analysis conducted by the Drug Testing Laboratories Punjab.
The Details of affected product batches are tabulated below
:-

Therapeutic Good(s) Affected: –

S#Product NameCompositionBatch No.Manufactured byTest Results  
01Zonid Suspension 120ml Reg# 022579Metronidazole 200mg/5mlZ266M/s. Bloom Pharmaceuticals (Pvt.) Ltd., Hattar.Contains Ethylene Glycol Above Permissible limits  
02Hedazol Suspension 60ml Reg# 046146Metronidazole 200mg/5ml7037M/s. Heal Pharmaceuticals (Pvt.) Ltd., Peshawar.-do-
03Vometol Suspension 120ml Reg# 094719Domperidone 5mg/5ml1347M/s. Roryan Pharmceutical Industries (Pvt.) Ltd., Peshawar.-do-
04Tritadin Syrup 60ml Reg# 096413Loratadine 1mg/ml005M/s. Trillium Pharmaceuticals (Pvt.) Ltd., Faisalabad.-do-
Action InitiatedThe manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock should be quarantined and returned to the supplier/ company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, by phone at +92 51 9255969, or by Email at gsmsdra.gov.pk.

-The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance to ensure the effective recall of defective product(s).
Advice for Healthcare 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 products bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Rapid Alert: Drug Product; Suspected Falsified Rabies Vacine

Rapid Alert

DRAP Alert NoNo I/S/09-24-37
Action Date27th September 2024
Target Audience·         Regulatory Field Force.
·         Healthcare Professionals – Physicians, Pharmacists, and Nurses.
·         Hospitals, Clinics, Pharmacies and other Healthcare Institutions
·         General Public.
Problem StatementDRAP has received information about the presence of a suspected rabies vaccine in the supply chain. The product is not registered by DRAP and may be a falsified product.
Product NameBatch/Lot No.Stated ManufacturerMfg. dateExp. date
Rabies Vaccine, Human IP
(SURE RAB)  
(unregistered)
RO10821M/s Bio-Med Private Limited,
C-96, SITE No. 1, B.S. Rd. Indi, AREA, Ghaziabad
(U.P.) – 201009,INDIA.
10-202310-2026
Threat to Public HealthRabies vaccine is used for the prevention of rabies in children and adults resulting from dog bite. Falsified rabies vaccines pose a significant threat to public health as the safety and efficacy of such products cannot be established therefore failing to provide adequate immunity, leaving individuals vulnerable to rabies infection
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 this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product.
Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product.

-Adverse 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 stop using this product and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre

All therapeutic 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 Products; Recall of 11 Substandard Batches from the Market

Recall Alert

DRAP Alert NoNo I/S/09-24-36
Action Date26th September 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue The Directorate of Drugs Control (DDC) in Punjab has identified the following substandard batches of pharmaceutical products based on analyzing their samples from Drug Testing Laboratories, revealing out-of-specification results.
The Details of affected product batches are tabulated below
:-

Therapeutic Good(s) Affected: –

Human Use Products

S#Product NameCompositionBatch No.Manufactured byTest Results
01Painsa 75mg/3ml Injection
Reg. No. 077269
Diclofenac SodiumPA415M/s. Wimits Pharmaceuticals (Pvt.) Ltd., Lahore.Substandard
02Metroin Infusion 100ml  

Reg.No 071279
Metronidazole 500mg/100mlMT24-058, MT24-060, MT24-061, MT24-062, MT24-063M/s. Saturn Pharmaceuticals (Pvt.) Ltd., Lahore. Substandard

Veterinary Use Products

Sr.Product NameCompositionBatch No.
Manufactured by
Test Results
03Oxytocin Injection

Reg.No 019928
Oxytocin
10 I.U/ml
V6-143M/s. ISIS Pharmaceutical & Chemical Works, Karachi.Substandard
04Selmec Injection 50ml

Reg.No. 071087
Ivermectin 20mg/mlSN-113M/s. Selmore Pharmaceuticals (Pvt.) Ltd., Lahore.Substandard
05Rasomycin-10 Injection

Reg.No. 003791
Oxytetracyclin 100mg/mlVJ. 1340M/s. Star Laboratories (Pvt.) Ltd., Lahore.Adulterated
06Rasomycin LA 20% Injection

Reg.No. 003791
Oxytetracyclin 200mg/mlVG. 1626M/s. Star Laboratories (Pvt.) Ltd., Lahore.Adulterated
07Rasomycin-5 Injection

Reg.No 003791
Oxytetracyclin 50mg/mlVK. 1467M/s. Star Laboratories (Pvt.) Ltd., Lahore.Adulterated
Action InitiatedThe manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock should be quarantined and returned to the supplier/ company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, by phone at +92 51 9255969, or by Email at gsmsdra.gov.pk.

-The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance to ensure the effective recall of defective product(s).
Advice for Healthcare 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 products bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Rapid Alert: Crackdown Against Spurious/falsified Drug Products

Rapid Alert

DRAP Alert NoNo I/S/09-24-35
Action Date24th September 2024
Target Audience·         Regulatory Field Force.
·         Healthcare Professionals – Physicians, Pharmacists, and Nurses.
·         Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions
·         General Public.
Problem StatementThe Directorate of Drugs Control (DDC) Punjab has detected the following falsified drug products based on their analysis from Drug Testing Laboratories (DTLs).The details of identified products and their batch details are as under:
S#Product NameCompositionBatch No.Manufactured by
(as per label)
Test Results
01Solveron 10mg Tablets  Dydrogesterone 10mgSVN-001M/s. Solvay, Plot# 32, Sector 2, Highway Petaro Road, Jamshoro.Spurious
02Carenol Syrup 450ml  Ammonium chloride 125mg/5ml, Sodium Citrate 55mg/5ml, Chlorphenramine Maleate 2.5mg/5mlCL-012M/s. Well Care Pharmaceuticals, A/7 P.S.I.E. Sargodha.Spurious and Misbranded
03Procain Penicillin Fort 4000000 I.U. Injection  Procaine Penicillin 3000000 I.U., Benzyl Penicillin 1000000 I.U140475M/s. Yanzhou Xier Kangtai Pharm. Co. Ltd., China. Sole agent: United International, 301 Madian Center, Plot No. MR-1/122, 3rd Floor, Kutchi Gali No. 2, Marriot Road, Karachi.Spurious
04Simgesic TabletTramadol HCl 37.5mg, Paracetamol 325mgB1985M/s. Siam Pharmaceutical, Plot No. 217, Industrial Triangle, Kahuta Road, Islamabad.Spurious and Misbranded
05Meronem 500mg InjectionMeropenem 500mg4B23D121ACS Dobfar S.p.A Viale Addetta 4/12, Tribiano, Milan Italy. Packed and Marketed by: Pfizer Pakistan Limited Karachi.Spurious and Substandard
06Meronem 1g InjectionMeropenem 1gm4A23A31ACS Dobfar S.p.A Viale Addetta 4/12, Tribiano, Milan Italy. Packed and Marketed by: Pfizer Pakistan Limited Karachi.Spurious and Substandard
Note: The red color font in the table indicates fake products and manufacturers’ names. These are not licensed or registered by DRAP.
Threat to Public HealthSpurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions. The safety and quality of the falsified products referenced in this alert is 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 this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product.
Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product.

-Adverse 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 stop using this product and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre

All therapeutic 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; Promass 1g/100mL Inf by M/s Treat Pharmaceutical, Bannu

Recall Alert

DRAP Alert NoNo I/S/09-24-34
Action Date23rd September 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
– General Public
Problem / Issue The Provincial Drug Inspector, Dera Ismail Khan, KPK collected the samples of Promass 1g Infusion and sent for analysis. The provincial Drug Testing Laboratory, KPK, Peshawar has declared batch No 034 of Promass 11g Inf, manufactured by the M/s Treat Pharmaceutical Industry, Bannu, as a substandard product.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Promass 1gm/100ml Inf

Reg.No. 075336
ParacetamolBatch No. 034
 
Mfg Date:01-07-2023
Exp Date:30-06-2025
M/s. Treat Pharmaceutical
Industry (Pvt.) Ltd, Kohat Road, Bannu
Risk Statement:Identification of visible particles in infusion products is a serious indicator of substandard quality, which can lead to significant health risks including severe reactions such as shivering, high fever, arterial blockages, infarction and more serious adverse events.
Action InitiatedThe manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of products. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) also increased surveillance in the market to ensure the effective recall of defective products(s).

Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at 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: Recall of Contaminated Liquid Preparations

Rapid Alert

DRAP Alert NoNo I/S/09-24-33
Action Date10th September 2024
Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
· General Public
Problem / Issue The Directorate of Drugs Control (DDC), Punjab has identified contamination of Ethylene Glycol in following liquid preparations. Drug Testing Laboratories (DTLs) have declared these batches of products as Substandard based on their analysis which revealed the presence of Ethylene Glycol exceeding limits. T

Therapeutic Good(s) Affected: –

The details of the affected batches are as follows:

S#Product NameCompositionBatch No.Manufactured by
01Texcol EX Syrup 120ml   Reg. No. 030897Aceylline Piperazine 45mg/5ml, Diphenhydramine HCl 8mg/5ml63864M/s. Razee Therapeutics (Pvt.) Ltd., Lahore
02Speczine Syrup 120ml   Reg. No. 012597Promethazine HCl 5mg/5ml609 604 YZM/s. Spectrum Laboratories, Lahore
03Mexair Syrup 60ml   Reg. No. 02665Terbutaline Sulphate 1.5mg/5ml05-23 02-22M/s. Siza Int., Lahore
04Stazin Syrup 60ml   Reg. no. 026326Cetrizine HCl 5mg/5mlGI 83M/s. Munawar Pharma (Pvt.) Ltd., Lahore
05Zevirol Expectorant syrup 120ml
Reg. No. 009378
Dipenhydramine HCl 13.5mg, Ammonium Chloride 131.5mg, sodium citrate 55mg, Menthol 1mg4031P.D.H. Laboratories Lahore
06Stazin Syrup 60ml   Reg. No. 026326Cetrizine HCl 5mg/5mlGI83M/s. Munawar Pharma Lahore
07Zevirol Expectorant syrup 120ml   Reg. No. 009.78Diphenhydramine 13.5mg, Ammonium Choride 131.5mg4031M/s. P.D.H. Pharmaceuticals Lahore
08Aphylin Expectorant Syrup   Reg. No. 026635Aminophylline 32mg/5ml, Diphenhydramine 8mg/5ml, Amonium Chloride 30mg/5ml24C090M/s. Obsons Pharmaceuticals Lahore
09Resfyl Syrup   Reg. No. 057214Acefylline Piperzine 45mg/5ml,
Diphenhydramine 8mg/5ml
4A055M/s. Rasco Pharma Lahore
10Zonid Suspension 120ml   Reg. No. 022579Metronidazole 200mg/5mlZ492 Z246M/s. Bloom Pharmaceuticals Hattar
11Butamin Syrup 60ml   Reg. No. 016630Salbutamol 2mg4016M/s. P.D.H Pharmaceuticals, Lahore
12Nuocid Plus suspension 120ml   Enlst. No. 0327660558Zingiber Officinale 20mg/5ml, Mentha Piperita 40mg/5mlNC-S045M/s. Arber Pharma Lahore

Risk StatementDi-ethylene Glycol (DEG) and Ethylene Glycol (EG) contaminated oral preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences
Action Initiated-The manufacturers of products have been directed to immediately recall the defective batches of from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company.

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

-The 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 these defective batches of liquid products.  

-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: Recall of Contaminated Liquid Preparations

Rapid Alert

DRAP Alert NoNo I/S/09-24-32
Action Date06th September 2024
Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
· General Public
Problem / Issue The Directorate of Drugs Control (DDC), Punjab has identified contamination with ethylene glycol and diethylene glycol in the following liquid preparations. Analysis from Drug Testing Laboratories (DTLs) has declared these products as Substandard

Therapeutic Good(s) Affected: –

The details of the affected batches are as follows:

S#Product NameCompositionBatch No.Manufactured by
01Cestonil Plus syrup   Reg. No. 021843Thiamine 1.75mg, Riboflavin 2.62mg, Pyridoxine 1.54mg, Nicotinamide 10.50mg061357M/s. Razzee Therapeutics, Lahore
02Texcol DM 10mg/5ml syrup   Reg. No. 025034Dextromethorphan09980M/s. Razzee Therapeutics, Lahore
03Speczine 5mg/5ml Syrup   Reg. No. 012597Promethazine280 287M/s. Spectrum Laboratories, Lahore
04Aphylin Syrup   Reg. No. 026635Aminophylline 32mg, Diphenhydramine 8mg, Ammonium HCl 30mg24B056M/s. Obsons Pharmaceuticals, Lahore
05Zolint Suspension   Reg. No. 016494Furazolidone 25mg/5ml, Metronidazole 75mg/5ml24003M/s. Libra Private Ltd., Peshawar
Risk StatementDi-ethylene Glycol (DEG) and Ethylene Glycol (EG) contaminated oral preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences
Action Initiated-All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company.

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

-The 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 these defective batches of liquid products.  

-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: Crackdown Against Spurious/Falsified Drug Products

Rapid Alert

DRAP Alert NoNo I/S/09-24-31
Action Date06th September 2024
Target Audience·         Regulatory Field Force.
·         Healthcare Professionals – Physicians, Pharmacists, and Nurses.
·         Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions
·         General Public.
Problem StatementThe Directorate of Drugs Control (DDC) Punjab has detected the following falsified drug products based on their analysis from Drug Testing Laboratories (DTLs).

The details of the identified products are as under: –

S#Product NameCompositionBatch No.Manufactured by
(as stated on the label)
Test Results
01Ativan 2mg TabletsLorazepam17C7019Purported to be manufactured by M/s. Pfizer Pakistan, KarachiSpurious
02Marfix 400mg TabletCefiximeMK-0002M/s. Mirak Pharmaceutical, LahoreSpurious
03Payodine 10g/100ml SolutionPovidone-Iodine002709M/s. A.Mannan Lab, KarachiSpurious
04Froxime 400mg CapsuleCefiximeFRX-400/C-6M/s. Froxx Pharmaceuticals, KarachiSpurious & Misbranded
05Noa-Xime 400mg CapsuleCefiximenx-00525-02M/s. Noa Hemis Pharmaceuticals, KarachiSpurious & Misbranded
06Biovim InjectionBenzyl Penicillin 500000 IU, Procaine Penicillin 1500000 IUC. B-86M/s. Uniline Pharma, KarachiSpurious
07Novazone Plus DrenchOxyclonazde 3% w/v, Levamisole HCl1.5% w/v, Cobalt Sulphate 0.075% /v, Selenium Selenite 0.035%061M/s. Uniline Pharma, KarachiSpurious
Note: The red color font in the table indicates fake products and manufacturers’ names. These are not licensed or registered by DRAP. 
Threat to Public HealthSpurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions. The safety and quality of the falsified products referenced in this alert are 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 this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of these 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 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 stop using this product and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre

All therapeutic 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 Products; Recall of 11 Substandard Batches from the Market

Recall Alert

DRAP Alert NoNo I/S/09-24-30
Action Date06th September 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue The Directorate of Drugs Control (DDC) in Punjab and the Quality Control Board in Baluchistan have identified the following substandard batches of pharmaceutical products based on analyzing their samples from Drug Testing Laboratories, revealing out-of-specification results.
The Details of affected product batches is tabulated below
:-

Therapeutic Good(s) Affected: –

S#Product NameActive IngredientsBatch No.Manufactured byTest Results
01Zyocain gel 15gLidocaine HCL 2%244
275
M/s. Pharmawise Laboratories, LahoreSubstandard
02Metrorise injectionMetronidazole 500mg/100mlLV 2303M/s. Pak risen Pharmaceuticals, HattarSubstandard
03Safemed InjectionMetronidazole 500mg/100mlS-825M/s. Ahad International Pharmaceutical Ltd., DI KhanSubstandard
04Lyosafe InfusionLevofloxacinL-784M/s. Ahad International Pharmaceutical Ltd., DI KhanSubstandard
05Enzol-WFI injection  Sterile water for injection1240003M/s. Enzon Pharma, LahoreSubstandard
06Oxytofas InjectionOxytocinOTI-1419M/s. Intervac (Pvt.) Ltd., SheikhupuraSubstandard &Misbranded
07Painsa 75mg InjectionDiclofenac SodiumPA420M/s. Wimits Pharmaceuticals, LahoreSubstandard
08Midoven InjectionFurosemideH-21924M/s. Venus Pharma, LahoreAdulterated
09Mencobal InjectionMecobalamin083
084
M/s. Treat Pharmaceutical Industry, LahoreAdulterated
Action InitiatedThe manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock should be quarantined and returned to the supplier/ company.

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

-The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance to ensure the effective recall of defective product(s).
Advice for Healthcare 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 products bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.