In the last week of September,2025 Drug regulatory authority of Pakistan has issued many recalls of substandard, misbranded and adulterated batches of various medicines which includes two substandard batches of ASCARD 75mg tablet, all batches of AMLOSHINE 5mg and AMLOSHINE 10mg, and one batch of each of LIGNOZIN-A injection and SATAMIN injection.
So, let’s discuss in detail all the recalled batches and the reason for their recall from the market.
Intended Audience:
Regulatory Field Force of DRAP and Provincial Drug Control Departments
Healthcare Professionals
Pharmacies and Medical Stores
Substandard Batches of ASCARD 75 mg TABLET
DRAP alert no: No II/S/09-25-77 & No II/S/09-25-78
Composition: Each enteric coated ASCARD tablet consists of: Acetylsalicylic Acid (Aspirin BP) 75 mg
Batches: AR021L & AR046L
Manufacturer: Atco Laboratories, Karachi (DML # 000188)
Remarks: “Sub-Standard“ with regards to Related Substances Test showing the presence of Impurity C (Salicylic Acid), above the permissible pharmacopeial limits. Though, not life threatening but can cause gastric complications and related adverse effects in the patients especially in sensitive individuals.
All batches of AMLOSHINE Tablets (5mg & 10mg)
DRAP alert no: No II/S/09-25-80
Composition: Amlodipine (as Beysalte) 5mg & 10 mg
Batches: All batches of AMLOshine 5mg (Reg # 062420) & Tablet AMLOshine 10 mg (Reg. # 062419).
Manufacturer: Sunshine Pharmaceuticals, Gujranwala (DML # 000662)
Remarks: After the detection of three (7840, 7623, 7361) substandard batches of AMLOshine 5mg in June, 2025, inspection at the manufacturing unit “M/s Sunshine Pharmaceuticals. Emanabad, G.T. Road, Gujranwala (DML # 000662)” of AMLOshine was conducted which reveal many deviations from the principles of Good manufacturing practice (GMP), particularly in terms 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
Due to all the above mentioned deviations, panel directed manufacturer to initiate an immediate recall of all batches of AMLOshine Tablet 5mg (Reg # 062420) & Tablet AMLOshine 10 mg (Reg. # 062419).
Registration of these tablets are under suspension process.
Substandard Batch of Lignozin-A 2mL injection
DRAP alert no: No I/S/09-25-79
Composition: Each ml of LIGNOZIN-A injections consists of: Lignocaine HCI (BP)= 20mg & Adrenaline (BP)= 1:80,000
Batches: LG-001
Manufacturer: Trigon Pharmaceutical Raiwind road, Lahore (DML # 000342)
Remarks: Declared Misbranded as per under Section 3(s)(iv) of the Drugs Act, 1976 & “Sub-Standard“ as fail to comply with physical description test (presence of visible particles), pH Test & Assay of Adrenaline.
Substandard Batch of Satamin Injection
DRAP alert no: No I/S/09-25-79
Composition: Each ml of SATAMIN injections consists of Mecobalamin (J.P) = 500ug
Batches: MC24-030
Manufacturer: Saturn Pharmaceuticals Raiwind road, Lahore (DML # 000734).
Remarks: Adulterated’ under Section 3 (a) (v) of The Drugs Act 1976.
Actions Taken
The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned unregistered/falsified products.
Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.
Guidance for Healthcare Professionals
DRAP advises healthcare professionals to remain vigilant in pharmacies, healthcare facilities, and supply chains potentially affected by these products. Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.
Guidance for Consumers
Consumers must avoid these products. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.
Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.
References;
Drug Regulatory Authority of Pakistan. (n.d.). Recall alert – Class II: Tablet Ascard 75. Retrieved from https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-class-ii-tablet-ascard-75/
Drug Regulatory Authority of Pakistan. (n.d.). Recall alert – Tablet Ascard 75 (batch AR046L). Retrieved from https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-tablet-ascard-75-batch-ar046l/
Drug Regulatory Authority of Pakistan. (2025, September 26). Recall alert – Tablet AMLOshine (all strengths & batches) – Sunshine Pharmaceuticals. Retrieved from https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-tablet-amloshine-all-strengths-batches-sunshine-pharmaceuticals/
Drug Regulatory Authority of Pakistan. (n.d.). Recall alert – Drug products (Class I). Retrieved from https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-drug-products-class-i/
