尼扎替丁口服溶液 15 毫克/毫升-因 NDMA(硝基二甲基胺)杂质而回收, Bridgewater, New Jersey, USA
4年前
Bridgewater Township, New Jersey, United States
Company name: Amneal Pharmaceuticals, LLCBrand name: Gemini Laboratories
Product recalled: Nizatidine Oral Solution 15 mg/mL
Reason of the recall: NDMA (Nitrosodimethylamine) impurity
FDA Recall date: April 15, 2020
Recall details: Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06598004A. Expiration Date: 04/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599001A. Expiration Date: 12/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599002A. Expiration Date: 12/2020
The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.
Check the full recall details on www.fda.gov
Source: FDA | 症状: 胃酸倒流
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3天前 •source www.fda.gov
Recall notice
肉鸟饮食中缺乏维生素D会导致矿物质缺乏和骨骼问题,包括成长中的鸟类出现软骨病。症状包括跛行和骨头呈橡胶状。
召回的商品是:
-产品:Nutrena® Country Feeds® Meatbird 22% Crumble(RV),尺寸:50 磅袋装,批次代码:所有批次,产品代码:95188,物种:肉鸟(肉鸡、火鸡、鸭子、鹅和野鸡),生产日期:2022年7月至2024年3月,保质期(天):120。
批号和生产日期可以在标签的右下角找到。
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公司名称:嘉吉
品牌名称:Nutrena Country Feeds
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召回原因:不含维生素 D
美国食品药品管理局召回日期:2024 年 4 月 13 日
来源:www.fda.gov
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