|DRAP Alert No||NoI/S/10-22-25|
|Action Date||7th October 2022|
|Target Audience||1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores|
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
3. General Public
|Product(s) Affected||Human Albumin 20% 100mL (Biotest), |
Active Ingredient(s): Serum Albumin 20% (Human)
Company: M/s. Biotest Pharma GmbH, Germany imported by M/s Eastren Trade & Distribution Co, (Pvt) Limited, Karachi
Batch No. C236831P02
Manufacturing Date: 17-Sep-2021,
Expiry Date: 31-Aug-2024
|Problem Statement||DRAP has received a rapid alert from the Paul-Ehrlich Institut, Federal Institue of Vaccine and Biomedicines, Ministry of Health, Germany, with respect to the quality defect and voluntary recall of 06 batches of Human Albumin 20%, 100mL manufactured by the Botest AG, GmbH. Out of these six batches, one batch was imported in Pakistan by the authorized registration holder M/s Eastren Trade & Distribution Co, (Pvt) Limited, Karachi.|
|Action Initiated||The importer has been directed to immediately recall the stock of defective batch C236831P02 from the market. Regulatory field force is directed to supervise the recall progress.|
-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.