DRAP RECALL ALERT-JUNE 2025
Drug regulatory authority of Pakistan (DRAP) is responsible for the regulation of drugs and therapeutic drugs in Pakistan. DRAP ensure the safety and efficacy of all the drugs and therapeutic good that are manufactured, sold, stocked or offered for sale
One of the key actions taken by DRAP to protect public health is the recall of defective or potentially harmful medicines from the market. These recalls are based on drug testing and analysis reports generated by Drug Testing Laboratories (DTLs) across Pakistan.
In June-2025, upon the inspection of the provincial drug inspectors, some medicines were sent for the analysis by DTL as they were found to be suspicious during inspection. On having the reports of the drug testing labs, some of the below mentioned medicines of specified batches were found to be “sub-standard” and were subsequently recalled.
According to the World Health Organization (WHO), substandard medicines are authorized medical products that fail to meet quality standards or specifications. These medicines are legally produced and approved, but due to issues in manufacturing, storage, or transportation, they may contain the wrong amount of active ingredient, may not dissolve properly, or may be contaminated.
Product Names | Composition | Test Results |
AMLOshine Tablet Reg. No. 062420 Manufactured by: M/s. Sunshine Pharmaceuticals, | Each tablet contains: BATCH NO. 7840 | ‘Substandard’ on the basis of Impurities test. |
AMLOshine Tablet Reg. No. 062420 Manufactured by: M/s. Sunshine Pharmaceuticals, | Each tablet contains: BATCH NO. 7623 | ‘Substandard’ on the basis of Impurities test. |
AMLOshine Tablet Reg. No. 062419 Manufactured by: M/s. Sunshine Pharmaceuticals, | Each tablet contains: BATCH NO: 7361 | ‘Substandard’ on the basis of Impurities test. |
FLAZOL Infusion 100mL Reg. No. 070611 Manufactured by: M/s Bosch Pharmaceuticals (Pvt) Ltd., | Each 100ml vial contains: BATCH NO: F250028 | ‘Substandard’ on the basis of Bacterial Endotoxin Test. |
Reference:
Drug Regulatory Authority of Pakistan. (2025, June 10). Recall alert: Products declared substandard by provincial drug testing laboratories [Webpage]. DRAP. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-products-declared-substandard-by-provincial-drug-testing-laboratories-4/
