Get an alert when a recall is issued. Do not use • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. Metformin HCl 500 mg Extended Release Tablets, 100 count bottle: 53746-178-01: All Lots: 06/2020-07/2021: Amneal Pharmaceuticals: Metformin HCl 500 mg Extended Release Tablets, 500 count bottle GRANULES PHARMACEUTICALS INC. is recalling Gabapentin Tablets USP, 600mg. This recall is due to a potential mix-up of Metformin ER Tablets in a bottle of Gabapentin Tablets, USP 600mg. Drug Recall Enforcement Report Class III voluntary initiated by Sciegen Pharmaceuticals Inc, originally initiated on 02-17-2023 for the product Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05. The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label. Metformin HCl Extended Release Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to Patients who accidentally take metformin instead of their gabapentin could potentially be at risk for seizures or nerve pain depending on the condition being treated. Additionally, patients could suffer adverse effects from the unwanted metformin including nausea, vomiting, diarrhea, upset stomach, or metallic taste. Metformin is not the only medication that has been evaluated or recalled by the FDA for higher-than-acceptable levels of NDMA. In recent years, valsartan, a blood pressure-lowering medication, and ranitidine, a heartburn medication, were recalled and removed from the market due to NDMA. Visit Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products. Follow FDA Recall Information on X (formerly Twitter). FDA provides a searchable list of recalled products. Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status; D-0248-2025: 02-18-2025: Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01. The study uses data from the FDA. It is based on gabapentin and metformin hydrochloride (the active ingredients of Gabapentin and Metformin, respectively), and Gabapentin and Metformin (the brand names). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. this recall. Why are these companies recalling their metformin ER tablets? • The companies are recalling this medication because some lots (batches) of the medication contain an impurity known as N-Nitrosodimethylamine (NDMA). o NDMA is most commonly found in some drinking water supplies and cured meats such as bacon, ham, sausages, and hot dogs. The last Recall Enforcement Report for Gabapentin with NDC 70010-228 was initiated on 07-31-2024 as a Class II recall due to presence of foreign tablets; 3 fused tablets of metformin er 500 mg were found in bottle of gabapentin tablets The latest recall number for this product is D-0634-2024 and the recall is currently ongoing . (Note: If you’re taking the brand-name versions of metformin—Fortamet, Glucophage, Glucophage XR, Glumetza, or Riomet—your medication was not affected by the recalls.) To check if your metformin medication was recalled, you can search the FDA’s list of recalled metformin drugs by clicking here and following the steps below. Drug Recall Enforcement Report Class II voluntary initiated by Granules Pharmaceuticals Inc., initiated on 07-31-2024 for the product Gabapentin Tablets, USP, Metformin in other countries was reported to have low levels of NDMA, although levels were within the range that naturally occurs in some foods and in water. The agency is testing for the impurity in samples of metformin sold in the U.S. but noted that there are no domestic metformin recalls at this time. The last Recall Enforcement Report for Gabapentin with NDC 70010-227 was initiated on 07-31-2024 as a Class II recall and it is currently ongoing. multiple manufactuers are recalling Metformin 500mg and 700mg Extended Release Tablets due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. Nerve Pain, Seizure Drug Recalled. The Harvard Drug Group is pulling 3984 cartons of gabapentin tablets after a foreign tablet was found in a carton, according to the May 17, 2023, US Food and Drug Administration (FDA) Enforcement Report. Sciegen Pharmaceuticals Inc states that the Immediate release tablets Metformin Hydrochloride Tablets, USP 500 mg, 850 mg & 1000 mg manufactured by Sciegen Pharmaceuticals Inc are not part of recall regarding Metformin products. Sciegen Metformin IR tablets complying to FDA requirements of NDMA content less 96 nanograms (0.0376 ppm).
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