Recall Alert
| DRAP Alert No | No I/S/05-23 |
| Action Date | 15th May 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | M/s. Brookes Pharma Private Limited, Karachi, has initiated a voluntary recall of all batches of Cadlec 30mg/ml Injection due to the presence of tiny floating particles found in retained samples. Previously, Ketorolac injection was also recalled by Fresenius Kabi, USA, and Hospira Inc. Additionally, Hikma Pharmaceutical, USA, also recalled the injection for the same reason. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Cadlec Injection 30mg/ml Reg No. 095892 | Ketorolac | All Batches | M/s. Brookes Pharma Private Limited, Karachi |
| Risk Statement: | Administering products containing particulate matter may block blood vessels, leading to local irritation, swelling, tissue inflammation, blood clots, lung tissue scarring, and life-threatening allergic reactions. |
| Action Initiated | –The manufacturer has initiated recall of all batches of the affected product from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying this product. The remaining stock should be quarantined and returned to the supplier/ company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). –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 to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 these product and shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic 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. |