Amneal recalls three nizatidine lots due to potential NDMA contamination
The FDA has said that Amneal Pharmaceuticals is recalling three lots of nizatidine oral solution at the consumer level due to potential NDMA contamination.
The US Food and Drug Administration (FDA) has announced that Amneal Pharmaceuticals, LLC is voluntarily recalling three lots of its nizatidine oral solution, 15mg/mL (75mg/5mL), packaged in 480mL bottles. The recall is being conducted down to the consumer level in the US.
The solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the acceptable levels established by the FDA. NDMA is classified as a probable human carcinogen based on results from laboratory tests.
The affected nizatidine lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA.
The nizatidine oral solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The drug is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of oesophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).
The company says it has not received any reports of adverse events that have been confirmed to be directly related to this recall. The FDA advises customers with the affected batches to stop using their medication and report any adverse reactions.
The three lot numbers being recalled can be found here.