Nizatidine Oral Solution 15 mg/mL - recalled due to NDMA (Nitrosodimethylamine) impurity, Bridgewater, New Jersey, USA
4 years ago •source fda.gov • details
Regulatory Report
Company name: Amneal Pharmaceuticals, LLC
Brand name: Gemini Laboratories
Product recalled: Nizatidine Oral Solution 15 mg/mL
Reason of the recall: NDMA (Nitrosodimethylamine) impurity
FDA Recall date: April 15, 2020
Recall details: Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15…
Brand name: Gemini Laboratories
Product recalled: Nizatidine Oral Solution 15 mg/mL
Reason of the recall: NDMA (Nitrosodimethylamine) impurity
FDA Recall date: April 15, 2020
Recall details: Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15…
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