Read about our culture . Such risks and uncertainties include, but are not limited to, risks related to the products and recall thereof described in this press release. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDAWe comply with the HONcode standard for trustworthy health information - Select one or more newsletters to continue. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. These forward-looking statements are based on current expectations of future events. Copies of these filings are available online at www.sec.gov, www.amneal.com or on request from the Company. MFR Clobetasol Propionate 0.05 % (NDC 21922001707) ENCUBE ETHICALS MFR CombiPatch 0.05-0.25 MG/DAY (NDC 68968052508) NOVEN THERAPEUTICS MFR Junel 1.5/30 1.5-30 MG-MCG (NDC 00555902742) TEVA PHARMACEUTICALS USA MFR Lidocaine HCl 3 % (NDC 59088099703) PURE TEK MFR miSOPROStol 200 MCG (NDC … Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Available for Android and iOS devices.
Amneal to Virtually Participate at the Morgan Stanley Global Healthcare Conference September 1, 2020. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” and similar words are intended to identify estimates and forward-looking statements.The reader is cautioned not to rely on these forward-looking statements. Nizoral is a very good, medicated antidandruff shampoo with 1% Ketoconazole. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.Customers who purchased the impacted product directly from Amneal can call Inmar at (855) 319-4807, Monday – Friday, 8:00 am – 6:00 pm, EST, or e-mail at Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at 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.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Our culture. An official website of the United States government: Recalls, Market Withdrawals, & Safety Alerts
Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” and similar words are intended to identify estimates and forward-looking statements.The reader is cautioned not to rely on these forward-looking statements.
The recalls were issued after Amneal was notified by the FDA that 7 lots of Metformin ER tested positive for unacceptably high amounts of a carcinogenic chemical called N-Nitrosodimethylamine (NDMA). In response, Amneal recalled those 7 lots, and extend the recall to all lots of metformin ER (500-mg and 750-mg) out of an “abundance of caution Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy.
Amneal to Virtually Participate at the Morgan Stanley Global Healthcare Conference September 1, 2020. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” and similar words are intended to identify estimates and forward-looking statements.The reader is cautioned not to rely on these forward-looking statements. Nizoral is a very good, medicated antidandruff shampoo with 1% Ketoconazole. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.Customers who purchased the impacted product directly from Amneal can call Inmar at (855) 319-4807, Monday – Friday, 8:00 am – 6:00 pm, EST, or e-mail at Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at 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.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Our culture. An official website of the United States government: Recalls, Market Withdrawals, & Safety Alerts
Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” and similar words are intended to identify estimates and forward-looking statements.The reader is cautioned not to rely on these forward-looking statements.
The recalls were issued after Amneal was notified by the FDA that 7 lots of Metformin ER tested positive for unacceptably high amounts of a carcinogenic chemical called N-Nitrosodimethylamine (NDMA). In response, Amneal recalled those 7 lots, and extend the recall to all lots of metformin ER (500-mg and 750-mg) out of an “abundance of caution Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy.