FDA is requiring new warnings about risk of respiratory depression in patients who use gabapentanoids with opioids or drugs that depress the nervous system The U.S. Food and Drug Administration (FDA) has reported that Aurobindo Pharma USA is voluntarily recalling Gabapentin 300 mg capsules from lot GESB14011-A in 100-count bottles. The product lot affected was found to include some empty capsules; thus, if taken by a person with seizures, they would The Food and Drug Administration sent out a nationwide recall alert for common generic drugs, some of which treat pain, allergies, and high blood pressure, due to manufacturing issues. Here's what 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. The recall affects gabapentin tablets, 600 mg, packaged in 100-tablet cartons (10 blister packs containing 10 tablets each, NDC 0904-6823-61), from lot T04468 (Exp 10/24). The cartons were Recall Enforment Report D-0354-2023 Recall Details 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. FDA inspectors found serious problems at a Glenmark factory in India that manufactured the recalled drugs. Another medication made there has been tied to deaths of U.S. patients. Usage, warnings, side effects, and community information for the prescription drug Gabapentin Dozens of generic medications—including some to treat conditions like high blood pressure, allergies, and high cholesterol—have been recalled.A Glenmark Pharmaceuticals factory in India did The latest safety updates on drugs - including duloxetine recall, new warnings for gabapentin-type drugs, tetracycline new warnings, and more. Drug Recall Enforcement Report Class II voluntary initiated by Granules Pharmaceuticals Inc., originally initiated on 07-31-2024 for the product Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05 The product was recalled due to presence of The US Food and Drug Administration (FDA) has announced a Class III recall for select lots of Gabapentin Capsules USP, 300 mg and 400 mg, manufactured by Sun Pharmaceutical Industries Ltd. in Gujarat, India, and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey. The recall affects 13 728 bottles—12 876 bottles of 300 mg capsules and 852 bottles of 400 mg capsules The most recent Recall Enforcement Report that covers this product was initiated on July 31st, 2024 and classified 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 This recall is currently terminated, and the associated recall number is recall number is D-0634-2024. It pertains to Gabapentin identified by The most recent Recall Enforcement Report that covers this product was initiated on April 24th, 2023 and classified as a Class III recall due to product mixup: one foreign tablet found in product. This recall is currently terminated, and the associated recall number is recall number is D-0570-2023. It pertains to Gabapentin identified by 0904-6823 as of 04-30-2024 . The most recent Recall Enforcement Report that covers this product was initiated on July 31st, 2024 and classified 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 This recall is currently completed, and the associated recall number is recall number is D-0634-2024. It pertains to Gabapentin identified by Nearly 40 generic medications—most prescription, but some sold over-the-counter at Amazon and Walmart—have been recalled due to manufacturing quality concerns, the FDA said. See the full list GABAPENTIN Recall D-0570-2023 Page Last Updated: May 19, 2023 Home FDA Recalls Class III Recalls, warnings, and alerts A warning that serious breathing problems may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. Risk factors include the use of opioids and other central nervous system depressants and conditions that reduce lung function, such as chronic obstructive pulmonary disease. Elderly Description: Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. Glenmark Pharmaceuticals recalls nearly 40 lots of generic medications over manufacturing issues impacting treatments for common health conditions. The FDA has reported out that, Sun Pharmaceutical Industries, Inc. initiated a recall for 13,728 bottles of gabapentin, including 12,876 bottles containing 300-milligram dosage and 852 bottles containing 400 milligrams per dose.
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