|DRAP Alert No||NoI/S/04-23-23|
|Action Date||16th February 2023|
|Target Audience||1. 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||Capex 500mg Tab|
Manufactured by: M/s. Rotex Pharma, Islamabad
Batch No. 2040006
|Problem / Issue||A video circulating on social media regarding the presence of a fly/insect in a liquid injection ampoule visible with the naked eye, apparently seems to be having adulterated quality. The matter is still under investigation, however as a precautionary measure, to prevent any public health hazard, the alleged drug is being recalled from the market.|
|Risk Statement||Drug Product reported to contain a hair punch within the tablet is of adulterated quality which may compromise the quality of drugs|
|Action Initiated||-The manufacturing company/registration holder has been directed to immediately recall the defected batch of product from the market.|
-All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this product batch. 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, or through phone at +92 51 910 73 17, or by 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 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 experienced any problem that may be related to taking or using this product.|
-All drug 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.