Parker Waichman LLP

Nizatidine Oral Solution Recalled

WASHINGTON, D.C. — Amneal Pharmaceuticals, LLC, announced that it must recall from consumer stores, wholesalers, distributors, and customers, the heartburn medication known as Nizatidine. According to Nasdaq.com, Amneal Pharmaceuticals recall program is due to a potential nitrosamine impurity in its medication called N-Nitrosodimethylamine, or NDMA. The U.S. Food and Drug Administration (FDA) permits the consumption […]

Nizatidine oral solution recalled

Nizatidine oral solution

WASHINGTON, D.C. — Amneal Pharmaceuticals, LLC, announced that it must recall from consumer stores, wholesalers, distributors, and customers, the heartburn medication known as Nizatidine. According to Nasdaq.com, Amneal Pharmaceuticals recall program is due to a potential nitrosamine impurity in its medication called N-Nitrosodimethylamine, or NDMA. The U.S. Food and Drug Administration (FDA) permits the consumption of small quantities of NDMA. However, the agency expressed concerns about the adverse health effects caused by ingesting amounts of NDMA higher than those tolerated by the FDA currently. Amneal Pharmaceuticals, based in Bridgewater, New Jersey, produces numerous drugs under generic names along with specialty pharmaceutical drugs. To this point, Amneal Pharmaceuticals is unaware of any adverse health events attributed to the consumption of Nizatidine.

Amneal Pharmaceuticals determined that recalling its Nizatidine oral solution in 15 mg/mL doses packaged in 480 mL bottles was the appropriate course of action to take in this circumstance. The recalled medication is available by prescription only. Amneal suggested that consumers check the expiration dates on the recalled oral solution to confirm the medication they have is part of the recall. The lots recalled expire in either April of 2020, or in December of 2020.

Amneal Pharmaceuticals’ recalled Nizatidine medication is prescribed by doctors to treat stomach distress such as treatment of ulcers, esophagitis, and heartburn typically associated with GERD, or gastroesophageal reflux disease.

The FDA had demanded a recall of Zantac and generic antacid medications containing ranitidine because of the possibility of excess NDMA consumption. The makers of Zantac, along with manufacturers of generic ranitidine products, withdrew their products from the marketplace out of an abundance of caution.

The FDA, in its safety announcement discussing the risks of NDMA consumption exceeding recommended limits, said that NDMA is identified as an environmental contaminant. The FDA also noted that NDMA is consumed by Americans daily in vegetables, meats, and dairy products as well.


What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value P&W worked on my 9/11 VCF claim and in retrospect I am so happy I chose them over the other firms who do the same. Ashley L. handled my claim and she was wonderful to work with. She was knowledgeable, responsive, and compassionate.
Shoshana Dornhelm
3 years ago
5 Star Reviews 150
robert francis
3 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value Parker Waichman is an excellent law firm. Thank you Christina Morace my Paralegal, assigned to the case for guiding me through the process of filing the necessary paperwork for the 9/11 victims compensation fund. Your knowledge and ability to communicate it to me made the entire process much easier..
allan doyno
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard, Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201