Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.
| DRAP Alert No | No II/S/01-26-129 |
| Action Date | 14 January, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Central Drug Laboratory (CDL) Karachi informed that the samples of below mentioned drug products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | DIFAM Injection 3ml Diclofenac Sodium (75mg/3ml) (Reg. # 014651-EX) | D260005, D260006 | M/s Bosch Pharmaceuticals (Pvt) Ltd. (DML # 000707) Plot No. 209 Sector 23 Korangi Industrial Area Karachi. | The samples have been declared “Sub-Standard” on the basis of assay test. |
| Risk Statement: | Use of a sub-standard injectable diclofenac may lead to therapeutic failure or overdose-related toxicity, including inadequate pain and inflammation control, gastrointestinal bleeding, kidney injury, cardiovascular complications, and injection-site reactions. The groups most likely to be affected include patients receiving injections for acute pain, post-operative pain, arthritis, trauma, and emergency care, particularly elderly patients, individuals with kidney, heart or gastric disease, and hospitalized patients, where incorrect dosing may result in serious and potentially life-threatening outcomes. |
| Action Initiated | – The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks 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 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 bearing the affected batch number(s). They 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. |