Recall Alert
Immediate Withdrawal of all batches of AMLOshine Tablet 5mg (Reg # 062420) & Tablet AMLOshine 10 mg (Reg. # 062419)
manufactured by M/s Sunshine Pharmaceuticals
| DRAP Alert No | No II/S/09-25-80 |
| Action Date | 26 September, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | In continuation to DRAP Alert No. NoII/S/05-25-45 dated 2nd June 2025, wherein three batches (7840, 7623, 7361) of Tablet AMLOshine 5mg [contains Amlodipine (as Beysalte) 5mg] bearing Reg. # 62420, and manufactured by M/s Sunshine Pharmaceuticals. Emanabad, G.T. Road, Gujranwala (DML # 000662) declared ‘substandard’ by Provincial Drug Testing Laboratory on the basis of impurities testing. The panel of inspectors of DRAP accordingly conducted inspection at manufacturing unit of M/s. Sunshine Pharmaceuticals, Khan Payara, Near Saim Nala, Emanabad, Gujranwala, revealed multiple critical non-compliances with Good Manufacturing Practices (GMP). These included the absence of vendor qualification, failure to perform impurities testing and analytical method validation, unjustified use of API overages, lack of process validation, failure to investigate assay deviations observed in stability data, and the non-availability of impurity reference standards. The panel advised firm to initiate an immediate recall of all batches of AMLOshine Tablet 5mg (Reg # 062420) & Tablet AMLOshine 10 mg (Reg. # 062419). Registration of Tablet AMLOshine 5 mg (Reg. #062420) and Tablet AMLOshine 10 mg (Reg. # 062419) are under suspension proceedings. |
| Risk Statement: | The presence of impurities, lack of validated testing, and failure to investigate assay deviations in AMLOshine Tablets may compromise product quality, leading to reduced therapeutic efficacy and potential treatment failure in patients requiring amlodipine for hypertension and cardiovascular conditions. Such deficiencies may also expose patients to unpredictable adverse effects, particularly among the elderly, long-term users, and those with comorbidities. In view of the nature of defect and potential health risks, the issue is classified as a Class II Recall, as the defect may cause illness or treatment failure but is not considered immediately life-threatening. |
| 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. |