Home > 2024 > September

Month: September 2024

Rapid Alert: Crackdown Against Spurious/Falsified Drug Products

Asad Ullah Recall Alerts
Download

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

Asad Ullah Recall Alerts

Recall Alert

Download

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 Initiated–The manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock should be quarantined and returned to the supplier/ company.

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

-The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance to ensure the effective recall of defective product(s).
Advice for Healthcare 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.