Amneal Pharmaceuticals controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
Back to profile1 entries
2019
Amneal recalls ranitidine products over potential NDMA impurity
Recall announced
Amneal Pharmaceuticals issued a voluntary consumer-level recall of specified ranitidine tablets and syrup because they could contain NDMA amounts above levels established by the FDA. The article reports no confirmed adverse events directly related to the recall.
Company response
Recall — Amneal Pharmaceuticals
Amneal Pharmaceuticals has issued a voluntary recall of its ranitidine tablets, 150 mg and 300 mg, as well as ranitidine syrup (ranitidine oral solution, USP), 15 mg/mL.
Source excerpt
Amneal Pharmaceuticals has issued a voluntary recall of its ranitidine tablets, 150 mg and 300 mg, as well as ranitidine syrup (ranitidine oral solution, USP), 15 mg/mL, to the consumer level, according to a company announcement.
The recall is due to potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.