ISLAMABAD: The Drug Regulatory Authority Pakistan (DRAP) has issued an immediate recall alert for a number of substandard, falsified and spurious pharmaceutical products after receiving various complaints from provincial health authorities and senior drug inspector Islamabad Capital Territory (ICT).
According to DRAP, the Directorate of Drugs Control (DDC) Punjab and Senior Drug Inspector ICT Islamabad has informed DRAP that samples of the following products have been reported substandard due to presence of impurities by Drug Testing Laboratory (DTL) Lahore and Rawalpindi:
(i) Ame-Pin injection 2ml consist of Tramadol HCl 100mg batch number TD-038 manufactured by Ameer Pharma (Pvt) Ltd, 23 km, Sheikhupura Road, Lahore;
(ii) Aqua-P injection consist of sterile water for injection batch number P-665 manufactured by Ipram International, Plot No 26, SS-3, NIZ, Rawat, Islamabad;
(iii) Flagyl Infusion consist of Metronidazole 500mg batch number AD460 manufactured by Sanofi-Aventis Pakistan Ltd, Plot No 23, Sector 22, KIA, Karachi;
(iv) Metroin Infusion consists of Metronidazole 500mg batch number MT24-103 manufactured by Saturn Pharmaceuticals, 23km, Thokar-Raiwind Rd, Lahore;
(v) Euro-Flow Cannula consists of IV Cannula batch number 24/87 manufactured by Euromed for Medical Industries SAE Cairo, Egypt;
(vi) Rudazole Injection consists of Metronidazole 500mg batch number RD-044 manufactured by Rukha Pharmaceutical & Laboratories, 537-D&E Sundar Industrial Estate, Lahore;
(vii) Safemed Injection consists of Metronidazole 500mg batch number S-699 manufactured by Ahad Intl, Pharmaceutical, 13kmGomalUni, Multan Road, DI Khan ;and
(viii) Pulmowell 120ml syrup a combination of (Ammonium Chloride 30mg, Liquorice Ext 50mg, Aniseed Oil 2.6ml batch number PLW-001 manufactured by Vital Phyto Parma (Pvt) Ltd, 7km from GT Road, SohawaChakwal Road, Rawalpindi.
DRAP launches crackdown on spurious drugs
According to the DRAP, the use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immuno compromised individuals, as well as pediatric and geriatric population.
The DRAP, following the information, started a crackdown against all such products and has issued recall alerts with directing the National Regulatory Field Force (NRFF), provincial drug control departments, pharmacists, chemists in distribution, pharmacies/medical stores, healthcare professionals- physicians, pharmacists, nurses at hospitals/clinics general public to stop the use of purchase, sale, prescription and use of following drugs.
The manufacturers are directed to immediately recall the defective batches of products from the market. The field force under the administrative control of DRAP and provincial drug control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market.
The regulatory field force of DRAP and Provincial Drug Control departments have 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 the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.
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