Below please find a more detailed look into the timeline of the Zantac/Ranitidine litigation. We will continue to update this information as the case progresses and new details become available.
Sept. 9: Valisure, an online pharmacy and accredited laboratory, files a detailed Citizen Petition with the U.S. Food & Drug Administration (FDA), asking the agency to recall all products containing ranitidine. Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the “inherent instability” of the ranitidine molecule.
Sept. 13: FDA issues a statement alerting patients and healthcare professionals of NDMA found in samples of ranitidine. The agency stated it had learned that some of these medications, including Zantac and generic ranitidine, contained NDMA.
Sept. 23: Sandoz, a generic manufacturer or ranitidine, recalls all quantities and lots within expiry because of confirmed contamination with NDMA.
Sept. 24: The FDA alerts health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc.
Sept. 25: Apotex, a generic manufacturer of ranitidine, recalls tablets 75 mg and 150 mg tablets after the FDA found that some medications contained NDMA.
Oct. 22: Sanofi recalls all over-the-counter Zantac products (Zantac 150, Zantac 150 Cool Mint, Zantac 75) in the U.S. because of FDA testing results.
Oct. 23: Perrigo recalls all pack sizes of ranitidine worldwide due to the possible presence of NDMA. That same day, Dr. Reddy’s recalled all ranitidine medications sold in the U.S. due to confirmed contamination with NDMA above levels established by the FDA. Dr. Reddy’s generic products were also sold under Kroger, CVS, Walgreens, and CDMA brand products.
Oct. 25: Lannett (ranitidine syrup 15 mg/mL) recalls all lots within expiry of ranitidine syrup due to confirmed NDMA contamination. Also that day, Novitium recalls all quantities and lots within expiry of ranitidine hydrochloride capsules (ranitidine hydrochloride capsules 150 mg and 300 mg) in the U.S. because of the potential for NDMA contamination.
Nov. 4: A group of plaintiffs files a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federally filed Zantac lawsuits into one court for pre-trial proceedings.
Nov. 6: Aurobindo recalls one lot of ranitidine tablets 150 mg; 37 lots of ranitidine capsules 150mg and 300 mg, and ranitidine syrup 15 mg/mL due to the detection of NDMA in the finished product.
Nov. 8: American Health Packaging recalls eight lots of ranitidine syrup 150 mg/10 mL liquid unit dose cups to the consumer level due to the detection of trace amounts of NDMA. This recall was initiated in response to the recall by the manufacturer, Lannett Company (above), which included affected lots that were repackaged by American Health Packaging. Same day, Amneal recalls 150 mg and 300 mg ranitidine tablets, and ranitidine syrup 15 mg/mL because of potential contamination with NDMA.
Nov. 15: Golden State Medical Supply recalls all quantities and lots within expiry of ranitidine HCl 150 mg and 300 mg capsules to the consumer level because of the presence of NDMA above levels established by the FDA. This recall was based on the manufacturer’s recall (Novitium Pharma above).
Nov. 19: Precision Dose recalls five lots of ranitidine oral solution 150 mg/10 mL because of the potential presence of NDMA. This recall was initiated in response to the recall by the manufacturer (Amneal Pharmaceuticals, above).
Jan. 2: Emery Pharma files a Citizens Petition urging the FDA to suspend sales of all products containing ranitidine, to recall those that are already on the market, after finding that a combination of heat and time can raise levels of NDMA during storage, transport and shipping, after ranitidine leaves the manufacturer.
Feb. 6: Judicial Panel on Multidistrict Litigation (JPML) orders that Zantac lawsuits should be centralized in the Southern District of Florida.
April 1: The FDA requests that all Ranitidine (Zantac) products be removed from the market.
May 8: Founding Partner Roopal Luhana is appointed to Plaintiffs’ Steering Committee and one of six committee chairs (ESI/Document Production Committee) in the Zantac MDL.