On January 8, Mylan Pharmaceuticals recalled three lots of nizatidine in 150-mg and 300-mg dosages after tests detected trace amounts of a chemical impurity called NDMA (N-nitrosodimethylamine).
NDMA is a toxic substance that is classified as a “probable human carcinogen” by the International Agency for Research on Cancer.
The recalled batches of nizatidine were distributed between June 2017 and August 2018. The recall includes the following 3 lots:
- 0378-5150-91 Nizatidine Capsules, USP 150mg (Bottles of 60) 3086746 May 2020
- 0378-5300-93 Nizatidine Capsules, USP 300mg (Bottles of 30) 3082876 Jan 2020
- 0378-5300-93 Nizatidine Capsules, USP 300mg (Bottles of 30) 3082877 Jan 2020
Nizatidine is an antacid medication that is used for the short-term treatment of stomach ulcers. It is also used to treat esophagitis and heartburn due to Gastroesophageal Reflux Disease (GERD).
NDMA contamination in medications has led to a growing number of recalls and lawsuits involving people who developed cancer after taking Zantac (ranitidine) or blood pressure drugs like valsartan.
Mylan Pharmaceuticals is asking consumers to contact their physician or healthcare provider if they have experienced any problems that may be related to using these recalled medications.
Source: Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited