The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the healthcare providers of the recall of two (2) batches of Pantogen Injection “Sintong” by the Taiwanese FDA, with (Lot numbers 4DM1150 and 4DM0442), produced by Xindong Biotech Co. Ltd. The recall was initiated by the manufacturer following received customer complaints of abnormal colour.
The main components of Sintong include thiamine hydrochloride, riboflavin -5-phosphate sodium, pyridoxine HCL, Ascorbic acid (VIT C), niacinamide (nicotinamide), pantothenol and glucose monohydrate. It is mainly used after surgery (malignant tumors, burns, fever Diseases, thyroid poisoning, peritonitis, retroperitoneal rot and wound infection symptoms) when the supply of vitamins B and C is needed, or when food cannot be eaten due to gastrointestinal diseases or alcoholism. It can be combined with comprehensive amino acid and glucose solutions to supply vitamin B and C after surgery.
Possible Risks
The use of contaminated injection (drugs) can result to severe health issues treatment failure and Compromised drug effectiveness.
Product Details
The details of the products are as follows;
Product Name: PANTOGEN INJECTION “SINTONG”
Product Manufacturer: Xindong Biotechnology Co., Ltd.
Affected Batch Number: 4DM1150 and 4DM0442
NAFDAC implores importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the affected lots of the product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Anyone in possession of the affected lots is advised to immediately discontinue sale or use and submit stock to the nearest NAFDAC office. If you have used this product, or someone you know, have used it, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC………. Customer-focused, Agency-minded!!!
