Mylan initiates voluntary recall of three lots of nizatidine capsules

Mylan Pharmaceuticals announced a voluntary, nationwide recall of three lots of nizatidine capsules, USP (including the 150 mg and 300 mg strengths) following the detection of trace amounts of N-nitrosodimethylamine (NDMA) in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Ltd.

Mylan Pharmaceuticals announced a voluntary, nationwide recall of three lots of nizatidine capsules, USP (including the 150 mg and 300 mg strengths) following the detection of trace amounts of N-nitrosodimethylamine (NDMA) in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Ltd. To date, Mylan has received no reports of adverse events related to these batches. The three affected batches—lot numbers 3086746, 3082876, and 3082877—were distributed nationwide to wholesalers, mail-order pharmacies, community pharmacies, and a distributor between June 2017 and August 2018.