|DRAP Alert No||NoI/S/20-23-21|
|Action Date||20th April 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||Spadix 4mL Injection|
Composition: Phloroglucinol and Trimethylphloroglucinol
Manufactured by: M/s. Tabros Pharma, (Pvt) Ltd., Karachi
Batch No. 570
|Problem / Issue||A video is circulating on social media regarding presence of a fly/insect in a liquid injection ampoule visible with 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 market.|
|Risk Statement||Drug Product contains fly/insect is of adulterated quality which may compromise the standard quality of drugs as not being sterile. The sterility is a basic quality attribute of all Injectable drugs. In this case such adulterated drug may initiate but not limited to following reaction in patients/users|
(i) Anaphylactic shock in patients which may lead to death of patient
(ii) Skin rashes, itching, difficulty in breathing
(iii) Sub optimal to no therapeutic effect for indicated medical treatment.
|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 batch of product. The remaining stock should be quarantine and return to the supplier / 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.