The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the recall of Acetazolamide Tablets usp 125mg manufactured by an American pharmaceutical company, Rubicon Research Private Ltd, with batch number 30575HF1. The company recalled the affected lot due to contamination, dirty and discoloured tablets.
Acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion (e.g., some types of glaucoma), in the treatment of certain convulsive disorders (e.g., epilepsy), and in the promotion of diuresis in instances of abnormal fluid retention (e.g., cardiac edema).
Acetazolamide is a diuretic used in the treatment of swelling caused by heart disease. It also works by helping the body generate more urine so as to lose salt and excess water from the body. It can also treat seizures, certain types of glaucoma and prevent symptoms of altitude sickness.
Possible Risks
The use of contaminated tablets (drugs) can result to poisoning,treatment failure and Compromised drug effectiveness.
Product Details
The details of the affected product are as follows;
Product Name | Product Manufacturer | Batch No | NDC | Manufacture Date | Expiry Date |
Acetazolamide Tablets, USP 125 mg | Rubicon Research Private Ltd, An American pharmaceutical company | 30575HF1 | 72888-047-01 | December 2023 | November 2026 |
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 the 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!!!
