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The recall covers 7,107 bottles of duloxetine, the FDA said. The bottles include 500 delayed-release 20mg capsules. The lot number is 220128, with an expiration date of 12/2024. The U.S. Food and Drug Administration updated the risk level of an antidepressant recall to the second-highest level due to the product containing high levels of a cancer-causing chemical. Duloxetine Delayed-Release Capsules were recalled because the pills may contain high levels of a cancer-causing chemical. the FDA elevated the recall to a Class II which means there is "a Now, the FDA is assigning the second-highest risk level to the recall of Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, according to agency records and reported by The recall of the Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, was initiated on October 10 and has been given the second highest risk classification by the FDA What Duloxetine Users Should Do in the Wake of the Recall Per Mayo Clinic , Duloxetine, which is known by brand names Cymbalta, Drizalma Sprinkle, and Irenka, is used to treat depression and anxiety. CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. What is the Reason for Recall? Information describing how the product is defective. Product Quantity: 7,188/ 500 count bottles Product Quantity The amount of product subject to recall. Voluntary Mandated May 7, 2024 · Clinical Team. On May 4, 2024, the U.S. Food and Drug Administration (FDA) reported that Breckenridge Pharmaceutical, Inc., (Breckenridge) issued a retail level recall of duloxetine delayed-release capsules. This recall was initiated due to the presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine Duloxetine (marketed as Cymbalta) is included in the class of drugs called selective serotonin/norepinephrine reuptake inhibitors (SNRIs). This class of drugs is used to

treat depression, anxiety This Retail Level Recall affects the lots in the table below. Only the lots in the table below are being recalled due to presence of Nitrosamine Drug Substance Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Duloxetine is used to treat depression and anxiety. It is also used for pain caused by nerve damage associated with diabetes (diabetic peripheral neuropathy). Duloxetine is also used to treat fibromyalgia (muscle pain and stiffness) and chronic (long-lasting) pain that is related to muscles and bones. Duloxetine belongs to a group of medicines According to the most recent FDA Enforcement Report, Apotex is voluntarily recalling 1,356,262 30-count bottles of duloxetine delayed-release capsules, a generic of Cymbalta. It is also recalling Please be advised that Breckenridge Pharmaceutical, Inc. (Breckenridge) is performing a Retail Level Class II Recall of Duloxetine Delayed-Release Capsules, USP, 20mg, 30mg, 60mg, manufactured by Towa Pharmaceutical Europe, S.L. The lots listed below are being recalled due to presence of Nitrosamine Drug Substance Related Impurity (NDSRJ), N As a result, The Block Firm filed a class action on behalf of Duloxetine patients, seeking to hold Breckenridge accountable for selling adulterated drugs. The Duloxetine recall has now significantly expanded. In separate actions, the FDA announced a recall of over 18 million more pills associated with Breckenridge's drug application. A recall is a voluntary action taken by a company to remove a defective drug product from the market or warn patients and consumers about a potential risk. The list below includes voluntary drug The last Recall Enforcement Report for Duloxetine Delayed-release with NDC 51991-748 was initiated on 05-17-2024 as a Class II recall and it is currently. Search. Home; Lookup Tools. The information in this

website is intended for healthcare providers and consumers in the United States. The absence of a warning or notice for a given drug or The US Food and Drug Administration has recalled thousands of bottles of Duloxetine antidepressant, saying it contained high levels of a cancer-causing chemical. The federal agency has reportedly The last Recall Enforcement Report for Duloxetine Delayed-release with NDC 60429-166 was initiated on 05-13-2024 as a Class II recall due to cgmp deviations: presence of nitrosamine drug substance related impurity (ndsri), n-nitroso-duloxetine, above the proposed interim limit. The latest recall number for this product is D-0568-2024 and the Some bottles of the antidepressant duloxetine, sold under the brand name Cymbalta, were recalled due to the presence of a toxic chemical. The waffle recall is the latest in a series of listeria outbreaks, including a late July recall for more than 7.2 million pounds of Boar's Head deli meats that prompted the closing of the company's Virginia plant. The ready-to-eat meat and poultry item producer BrucePac also recently recalled more than 11.7 million pounds of product due to possible listeria contamination. デュロキセチン（Duloxetine）は、セロトニン・ノルアドレナリン再取り込み阻害薬（SNRI）と呼ばれる抗うつ薬の一つである。日本では2010年からサインバルタの商品名で知られる。薬機法における劇薬である。