FDA Announces Another Zantac Recall

FDA Announces Another Zantac Recall

Introduction

The U.S. Food & Drug Administrations (FDA) posted a recall notice on its website following which American Health Packaging recalled ranitidine tablets, as the heartburn medication contained unacceptable levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen.

The recall notice includes 11 lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters, which American Health Packaging has notified its distributor to arrange the return of all recalled ranitidine products to lnmar Pharmaceuticals Services.

An online pharmacy Valisure first announced that it had detected high levels of NDMA in every drug sample it tested, following which Zantac and ranitidine recalls began last year. The pharmacy petitioned the FDA, noting that the NDMA levels sometimes far exceeded the agency’s recommended guidelines. It also asserted that the ranitidine molecule resulted in the production of NDMA when the drug was subjected to conditions that mimic human digestion, which the agency is yet to determine.

The U.S. District Judge Robin L. Rosenberg has appointed two small groups of attorneys to serve in leadership roles presiding over the Zantac lawsuits. The pretrial order was issued on February 24, when Judge Rosenberg appointed four attorneys to an Initial Census Team and four other attorneys to a Practices and Procedures Team.

The Initial Census Team will focus on planning a process to survey the number of filed Zantac claims and unfilled cases that attorneys are investigating nationwide. Practices and Procedures Team will work on creating an early dialog regarding the content and timing of procedural orders that may be helpful in the Zantac litigation. The initial status conference is scheduled for March 20.

Earlier, the U.S. District Judge Robin L. Rosenberg, presiding over all federal Zantac lawsuits, appointed two small groups of attorneys to serve in leadership roles.

Zantac (ranitidine hydrochloride) is an antacid and an H2 (histamine-2) receptor blocker used for treating and preventing ulcers in the duodenum, stomach, and intestines. It is also used for treating erosive esophagitis, heartburn, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome. In 1983, Glaxo Holdings Ltd, a company which is a part of GlaxoSmithKline PLC, received approval from the FDA to sell Zantac in the U.S. However, owing to patent expiry in 1987 in the United States, Glaxo had to face stiff competition by the generic alternatives launched immediately by competitors. Since 2017, the OTC version of Zantac was marketed by Sanofi in the United States and Canada. In 2004, Pfizer gained FDA approval to sell the Zantac OTC in the United States.

According to the pretrial order issued on February 24, Judge Rosenberg appointed four attorneys to an Initial Census Team and four other attorneys to a Practices and Procedures Team.

The Initial Census Team will assist to outline the process for surveying the number of filed Zantac claims and unfiled cases that attorneys nationwide are continuing to investigate. This will help the Court gauge the size of the litigation and the best way to manage the pretrial proceedings.

The duties of the Practices and Procedures Team, as described in a pretrial order issued on February 20, include the creation of an early dialog regarding the content and timing of procedural orders that may be helpful in the Zantac litigation.

An initial status conference with the presiding judge is scheduled for March 20, during which the appointed attorneys will meet with the Court for the first time. A larger group of Zantac injury attorneys will be appointed around the time of this conference, who will take certain actions that benefit all plaintiffs and argue motions before the Court.