Recall Alert: 

M/s. Brookes Pharma Private Limited, Karachi, has issued a voluntary recall of all batches of Cadlec 30mg/ml Injection due to the presence of tiny floating particles found in retained samples. This issue has previously prompted similar recalls of Ketorolac injections by Fresenius Kabi, USA, Hospira Inc., and Hikma Pharmaceutical, USA. The affected product, registered under No. 095892, includes all batches of Cadlec Injection 30mg/ml Ketorolac manufactured by Brookes Pharma.



Risk Assessment:

Administering products containing particulate matter poses serious health risks. These particles can block blood vessels, leading to local irritation, swelling, tissue inflammation, blood clots, lung tissue scarring, and potentially life-threatening allergic reactions. To address this, Brookes Pharma has initiated a recall, and regulatory field forces, including DRAP and Provincial Health Departments, have increased market surveillance. Pharmacists and chemists must check their stocks immediately, stop supplying this product, and quarantine any remaining stock for return.

Advice for Healthcare professionals and consumers:

Healthcare professionals are advised to exercise increased vigilance within their supply chains. Any adverse reactions or quality problems should be reported to the National Pharmacovigilance Centre (NPC), DRAP. Consumers are urged to stop using Cadlec 30mg/ml Injection and contact their healthcare provider if they experience any related issues. Reporting incidents to the Drug Regulatory Authority of Pakistan is crucial. Ensure all therapeutic goods are purchased from licensed pharmacies and authorized outlets, and verify the authenticity and condition of the products.