Home > 2022 > December

Month: December 2022

Recall Alert: Drug Product; Ximex 100mg/5mL Suspension by Farmaceutics International Karachi

Asad Ullah Product Recalls, Recall Alerts, Safety Info

Recall Alert

DRAP Alert NoNoI/S/11-22-39
Action Date30th November 2022
Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Ximex 100m/5mL Suspension,
Active Ingredient(s): Cefixime 100mg/5mL
Company: M/s. Farmaceutics International Karachi
Batch No. F-C-539
Manufacturing Date: 06-2022
Expiry Date: 06-2024
Problem / Issue Federal Government Analyst, CDL Karachi has declared the batch No. F-C-539 of product ‘Ximex 100mg/5mL Suspension” manufactured by M/s. Farmaceutics International Karachi, as of substandard quality based on the analysis report.
Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.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 Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

-Adverse reactions or quality problems experienced with the use of this product may 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 Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

-All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
    Ximex-100mg-Suspension-Recall-AlertDownload

    Recall Alert: Drug Product; Kempol 120ml/5mL Pediatric Syrup by M/s Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad

    Asad Ullah Product Recalls, Recall Alerts

    Recall Alert

    DRAP Alert NoNoI/S/11-22-39
    Action Date30th November 2022
    Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
    2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
    3. General Public
    Product(s) Affected Kempol 120mg/5mL Syrup,
    Active Ingredient(s): Paracetamol 120mg/5mL
    Company: Ms. Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad
    Batch No. P-707
    Manufacturing Date: 09-2022
    Expiry Date: 08-2024
    Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. P-707 of product ‘Kempol 120mg/5mL Syrup” manufactured by M/s. Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad and declared it as “Substandard” based on the analysis.
    Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

    -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

    -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.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 Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

    -Adverse reactions or quality problems experienced with the use of this product may 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 Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

    -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
      Kempol-120ml-Syrup-Recall-AlertDownload

      Rapid Alert: Drug Product; Falsified Restane Inhalational Solution Identified and Confiscated

      Asad Ullah Product Recalls, Recall Alerts

      Rapid Alert

      DRAP Alert NoNoI/S/12-22-40
      Action Date1st December 2022
      Target Audience• Regulatory Field Force
      • Healthcare Professionals- Anesthesiologist, Surgeons, Pharmacists, and Nurses
      • Pharmacists and Chemists at Distribution, Institutional suppliers
      • General Public
      Problem StatementDuring the surveillance activities in different Hospitals of Punjab, Regulatory Field Force had drawn samples of this product for test/analysis. The Provincial Drugs Testing Laboratory, Faisalabad has declared the samples as spurious and adulterated.
      The product detail is as under: –

      Therapeutic Good Affected:-

      SrProduct NameCompositionBatch #Manufactured by (as stated on label)Marketed by
      (as label)
      1
      RESTANE Inhalation Solution 100ml
      		IsofluraneN0111B24
      N0892A10
      M/s Piramal Critical Care, Inc. Schelden Circle Bethlehem PA 18017, USA
      		Allied Distributors 103-K, Block-2 P.E.C.H.S, Karachi Pakistan.
      Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health Facilities (Hospitals) in addition to markets and confiscate these batches of product. All Pharmacists and chemists working at Hospital distributions and Pharmacies should immediately check the stock and stop supplying these batches of product. The remaining stock should be quarantined immediately, and supplier’s information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of this 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. Anesthesiologists and the supporting staff involved in surgical procedures where anesthetics are involved should remain vigilant about the suspected batches of said products.

      -Adverse reactions or quality problems experienced with the use of this product 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 Consumers-If you are intending to plan any surgeries where anesthetic procedures are involved, or you are an attendant to a such patient, you are requested to cross check the originality of this product with your healthcare professionals (e.g. physicians, surgeons, gynecologist, anesthesiologist, etc.) to ensure the originality of product.
      Suspected-Falsified-Product-in-market-Restane-Inhalation-SolnDownload