What You Should Know About The FDA Recall of Zantac

On April 1, 2020, The Food and Drug Administration (FDA) recommended the universal recall of all Zantac and ranitidine products from the U.S. market. The Zantac recall comes after various third party tests have found that unsafe levels of the probable human carcinogen NDMA can be produced in Zantac and ranitidine products as they are stored over time or when they are exposed to high temperatures.  The FDA Zantac recall includes both prescription and over-the-counter Zantac and ranitidine products.

Do I Have A Case?

Zantac has been on the market for over thirty years and millions of people have taken brand name product and its generic, ranitidine. For anyone currently taking these drugs, you should immediately contact your doctor to discuss your options.

What Is Zantac?

Zantac is a medication that limits the production of stomach acid and belongs to a class of medications known as H2 blockers. It is sold as a generic under the name of its active ingredient, ranitidine. Zantac is sold over-the-counter to treat heartburn and acid indigestion, and prescribed for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease, and certain stomach and esophagus conditions.

What Is NDMA?

NDMA is classified as a probable human carcinogen that can form as a byproduct of industrial processes or, as in Zantac, from exposure to high temperatures or storage over time. The chemical can be found in small quantities in drinking water but in levels that are considered generally harmless. The NDMA found in the recalled Zantac and ranitidine products is above levels considered safe by the FDA. NDMA had previously been found in the blood pressure medication Valsartan, which prompted a string of product recalls starting in July 2018.

NDMA exposure in Zantac and ranitidine has been linked to digestive system cancers such as:

  • Stomach cancer
  • Intestinal cancer (both of the small and large intestines)
  • Esophageal cancer
  • Prostate cancer
  • Pancreatic cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma
  • Bladder cancer
  • Stomach cancer
  • Colorectal Cancer
  • Liver Cancer
  • Kidney Cancer

Additionally, in babies born to mothers who took Zantac consistently throughout their pregnancies, NDMA has been linked to cancers, including brain cancers, in young children.

Zantac Recall Summary

Appco Pharma Ranitidine Recall

On January 8, 2020, Appco Pharma LLC announced a voluntary recall of all lots of its Ranitidine Hydrochloride capsules due to potential NDMA contamination. The recall includes all prescription Ranitidine Hydrochloride capsules in strengths of 150 mg and 300 mg manufactured and distributed by Appco and its marketing partner, ANI Pharmaceuticals.

Northwinds Pharmaceuticals Ranitidine Recall

On January 8, 2020, Denton Pharma, an affiliate of Northwind Pharmaceuticals LLC, voluntarily recalled all lots of prescription Ranitidine 150 mg and 300 mg tablets it had repackaged and distributed at the consumer level.  The recall in is response to the manufacturer’s recall of these medications, which had since been repackaged by Denton Pharma, due to concerns of potential NDMA contamination.

Glenmark Pharmaceuticals Ranitidine Recall

On December 17, 2019, Glenmark Pharmaceuticals Inc. issued a voluntary recall of its unexpired Ranitidine tablet products and halted product distribution due to worries over potential NDMA contamination. In total, 928 lots of Ranitidine 150mg and 300 mg tablets are affected in the recall.

Precision Dose Ranitidine Recall

On November 19, 2019, repackaging company Precision Dose Inc. voluntarily recalled 5 lots of Ranitidine Oral Solution–USP 150mg/ 10mL from the market. The ranitidine product is being recalled due to potential NDMA presence above the standards approved by the Food and Drug Administration.

The recall was initiated after manufacturer Amneal Pharmaceuticals, LLC) issued a voluntary recall which included lots repackaged by Precision Dose Inc.

Golden State Ranitidine Recall

On November 15, 2019, repackaging company Golden State Medical Supply, Incorporated (GSMS, Inc.) voluntarily recalled all quantities and lots of Ranitidine HCl 150mg and 300mg capsules due to the potential presence of NDMA above levels approved by the Food and Drug Administration.

The voluntary recall comes after GSMS, Inc received a recall notice from manufacturer Novitium on October 25, 2019 and initially recalled 7 lots of Ranitidine HCl 150mg and 12 lots of Ranitidine HCl 300mg capsules on November 6, 2019.

American Health Ranitidine Recall

On November 8, 2019, American Health Packaging voluntarily recalled 8 lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150mg/10mL Liquid Unit Dose Cups from the consumer market due to an “unexpected impurity” of NDMA detected in the finished products at levels deemed unsafe by the Food and Drug Administration.

The recall comes in response to manufacturer Lannett Company, Inc.’s voluntary recall of ranitidine products which included affected lots that were repackaged by American Health Packaging.

Amneal Ranitidine Recall

On November 8, 2019, Amneal Pharmaceuticals, LLC voluntarily recalled Ranitidine Tablets, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL that were distributed directly to wholesalers, distributors, retailers, and re-packagers due to potential NDMA levels deemed unacceptable by Food and Drug Administration standards.

Lannett Ranitidine Recall

On October 28, 2019 the FDA announced that Lannett Company, Inc. recalled all lots of its prescription ranitidine syrup. The recall includes Lannett’s ranitidine oral solution prescribed in 15mg/mL doses due to the confirmed presence of NDMA.

Novitium Pharma Ranitidine Recall

On October 25, 2019, the FDA confirmed that Novitium Pharma LLC recalled all lots of its over-the-counter Ranitidine Hydrochloride capsules in the United States. Novitium’s ranitidine recall includes all lots of 150 mg and 300 mg dosages sold in 30, 60, 100, and 500 count bottles. The FDA announcement states that the recall was due to potential unsafe levels of NDMA found in the capsules.

Perrigo Ranitidine Recall

On October 23, 2019, the FDA announced that Perrigo Company plc issued a worldwide recall of all lots of its over-the-counter ranitidine products. The announcement states that Perrigo halted shipments of its ranitidine products on October 8 due to the possible presence of NDMA. The Perrigo recall includes many popular ranitidine products, including the Publix over-the-counter store brand.

Dr. Reddy’s Ranitidine Recall

On October 23, 2019, the FDA announced that Dr. Reddy’s Laboratories, LTD. issued a voluntary recall of all lots of its ranitidine products – both prescription and over-the-counter – sold in the United States on October 1. This recall includes lots of ranitidine sold under store brand names at Walgreens, Target, Walmart, Kroger, and CVS. The ranitidine recall was initiated after product testing confirmed unsafe levels of NDMA. For a full list of products recalled under the Dr. Reddy’s ranitidine recall, visit the FDA recall page.

zantac-pill-containersSanofi Zantac OTC Recall

The FDA also confirmed on October 23, 2019 that Sanofi recalled all lots of its Zantac OTC (over-the-counter) medications sold in the United States and Canada on October 18. The company cited “inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products” as the reason for the recall. The Sanofi Zantac OTC recall includes all lots of Zantac 150, Zantac 150 Cool Mint, and Zantac 75.

Apotex Ranitidine Recall

On September 25, 2019, the FDA announced that Apotex Corp. voluntarily recalled its over-the-counter Ranitidine Hydrochloride tablets on a precautionary basis due to concerns of NDMA contamination. The Apotex ranitidine recall applied to 75 mg and 150 mg tablets sold under store brand names at Rite Aid, Walmart, and Walgreens pharmacies.

Sandoz Ranitidine Recall

On September 23, 2019, the FDA announced that Sandoz Inc. recalled all lots of its Ranitidine Hydrochloride capsules sold over-the-counter in the United States due to confirmed NDMA contamination. Sandoz is a subsidiary of the Swiss pharmaceutical conglomerate Novartis. The Sandoz ranitidine recall applies to 14 lots of Ranitidine 150 mg and 300 mg capsules sold in 30, 60, and 500 count bottles.

How We Can Help

GoldenbergLaw is currently investigating cases where an individual has taken Zantac or ranitidine and been diagnosed with one of the cancers listed above. Contact our Minnesota cancer attorneys today for a free consultation or call 612-436-5026. We have over 30 years of experience fighting negligent drug companies and have national leadership in NDMA contamination cases, let us deliver the Gold standard you deserve.

Losartan Recall Expands As Torrent Recalls Five More Lots

The Losartan recall continues to expand after the Food and Drug Administration (FDA) announced the recall of additional lots of the blood pressure medication due to fears of carcinogen contamination. The latest Losartan recall includes five lots manufactured by Torrent Pharmaceutical after the medication was found to contain unsafe levels of N-methylnitrosobutyric acid, or NMBA.

Why is NMBA Dangerous?

NMBA is a known animal carcinogen and believed to be a potential human carcinogen. Like NDEA and NDMA, the compounds found in previous Losartan and Valsartan recalls,  long term exposure to NMBA at unsafe levels could lead to development of certain types of cancers, including:

  • Liver Cancer
  • Stomach Cancer
  • Colon Cancer
  • Intestinal Cancer
  • Prostate Cancer
  • Lower Esophageal Cancer
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma
  • Leukemia
  • Pancreatic Cancer

When Was this Losartan Recall Announced?

The FDA announced the latest Torrent Losartan recall on September 19, 2019, and the company issued a formal announcement of the recall on September 23. This latest recall marks the sixth time that Torrent has recalled lots of its Losartan products due to potential carcinogen contamination since the recalls began in 2018.

Which Lots of Losartan Were Recalled?

The lots included in this latest Losartan recall are listed below:

NDC
Product Name, Strength and Package Count
Batch Number
Expiration Date
13668-409-10
Losartan Potassium Tablets, USP 50mg, 1000 count
4DU2E009
12/31/2020
13668-115-90
Losartan Potassium Tablets, USP 100mg, 90 count
4DU3E009
12/31/2020
13668-115-10
Losartan Potassium Tablets, USP 100mg, 1000 count
4DU3E018
02/28/2021
13668-116-90
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count
BEF7D051
11/30/2020
13668-118-90
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count.
4P04D007
07/31/2020

GoldenbergLaw Can Help

GoldenbergLaw is currently investigating cases where an individual has taken Losartan for at least a year, received a Losartan recall letter, and has been diagnosed with prostate cancer (before age 60), lower esophageal cancer, non-hodgkins lymphoma, leukemia, multiple myeloma, colon, stomach, intestinal, or pancreatic cancer. If you or a loved one has taken Losartan and been diagnosed with one of these cancers, please contact us today for a free consultation. We have over 30 years of experience holding drug manufacturers accountable for negligence, let us deliver the Gold Standard advocacy you deserve.

Allergan Issues Worldwide Recall of Breast Implant Products Due To Cancer Link

The FDA requested that the pharmaceutical company Allergan recall its textured breast implant products after discovering a connection between Allergan’s implants and a rare form of cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). In response, Allergan issued a worldwide recall of all of its textured breast implants and implant-related products.

What Is A Textured Breast Implant?

Allergan manufactures BIOCELL breast implants which include a uniquely textured shell-like surface to prevent the implant from slipping and minimizes scar tissue around the implants.

What Is BIA-ALCL and How Does A Textured Breast Implant Cause It?

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is not breast cancer but actually non-Hodgkin’s lymphoma (cancer of the immune system) that grows within the scar tissue surrounding the implants and may spread throughout the body. BIA-ALCL grows slowly and can usually be treated with surgery to remove the implant and surrounding scar tissue. However, some patients may require chemotherapy and/or radiation therapy.

Textured breast implants have a rougher surface intended to reduce an implant’s movement, but may also lead to the development of cancer cells due to the rough surface causing inflation and irritation to the surrounding tissue.

How Do I know If I Have BIA-ALCL?

Symptoms of BIA-ALCL Include:

  • Pain
  • Lumps
  • Swelling
  • Breast asymmetry

What Is The FDA Saying?

As of May 2019, the FDA said that the risks of BIA-ALCL in textured breast implants did not warrant a national ban. However, as of July 24, 2019 the FDA has issued an updated statement explaining that new data shows a direct link between cancer and specifically textured breast implants manufactured by Allergan.

The data has concluded that more than 80% of 573 lymphoma cases have been linked to Allergan implants and 33 cases have resulted in the patient’s death. In addition, risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.

FDA Principal Deputy Commissioner, Dr. Amy Abernethy, M.D., Ph.D., said in a statement regarding the textured breast implants that, “Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.”

How Common Is BIA-ALCL From Textured Breast Implants?

In countries such as France, Canada, and Australia BIA-ALCL from textured breast implants is common due to the products’ domination of the breast implant market by up to 80%. As a result, regulatory bodies similar to the FDA in these nations have already instituted bans on textured breast implants.

However, in the U.S., only 10% of all breast implants are textured breast implants. More specifically, macro-textured implants (the type Allergan manufacturers) are found in less than 5% of the breast implants marketed in the U.S.

Which Products Are Affected?

In response to the FDA uncovering cases of BIA-ALCL and BIA-ALCL-related deaths worldwide and the FDA’s request for a recall of all BIOCELL textured breast implants and tissue expanders marketed in the U.S., Allergan voluntarily issued a worldwide recall of their products.

Allergan’s textured breast implant recall includes:

  • Allergan Natrelle Saline-Filled Breast Implants
  • Allergan Natrelle Silicone-Filled Textured Breast Implants
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Allergan’s textured breast implant-related products include their tissue expander products used by patients prior to breast augmentation or reconstruction procedures:

  • Natrelle 133 Plus Tissue Expander
  • Natrelle 133 Tissue Expander with Suture Tabs

What Should I Do Now?

FDA Recommendations:

  • If you do not have symptoms from your breast implant, the FDA does not recommend having the implant removed due to low risk of cancer. However, speak to your health care provider about your concerns
  • Know the symptoms of BIA-ALCL and monitor the area around your breast implants
  • If you experience any symptoms, speak to your health care provider immediately to be evaluated
  • If your BIA-ALCL is confirmed by your health care provider, undergo implant and scar tissue removal surgery
  • Keep a record of the device manufacturer, device identifier, and implant model name (this information may be found on a patient device card from your surgeon or can be requested from your surgeon or the facility where your procedure was performed)
  • Know that most BIA-ALCL cases occur years after breast implant procedure
  • Talk with your surgeon regarding your risk of developing BIA-ALCL

What Should I Do If I Was Diagnosed With BIA-ALCL After Receiving Textured Breast Implants?  

If you or a loved one has been diagnosed with BIA-ALCL after using an Allergan textured breast implant, contact the Minnesota Cancer Attorneys at GoldenbergLaw. With over 30 years of experience fighting corporate negligence, we deliver the Gold standard advocacy you deserve.