Cancer-Causing Impurity Found in Popular Heartburn Aid, Zantac Generics

Update: Sandoz Inc. Joins recall of its ranitidine products in the 150mg and 300mg capsules, see product list below.

The heartburn or acid reflux aid, ranitidine, in 75 mg and 150 mg made by Apotex, is being recalled due to the potential for detection of an amount of unexpected impurity, N-nitrosodimethylamine (NDMA). It is noted that the affected Ranitidine Hydrochloride Tablets were distributed nationwide

Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. To date, Apotex has not received any reports of adverse events related to use of the product.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine Hydrochloride Tablet is an over the counter (OTC) oral product indicated for the relief of heartburn associated with acid indigestion and sour stomach and prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages. The affected Ranitidine Hydrochloride Tablets can be identified by NDC numbers stated on the product label.  

ProductStrengthPack SizeNDC Number
Ranitidine tablets, USP 150mg- acid reducer (Rite Aid)150 mg50’s Bottle11822-6052-1
Ranitidine tablets, USP 150mg- acid reducer (Rite Aid)150 mg65’s Bottle11822-6052-2
Ranitidine tablets, USP 150mg- acid reducer (Rite Aid)150 mg95’s Bottle11822-4727-3
Ranitidine tablets, USP 150mg- acid reducer (Walmart)150 mg65’s Bottle49035-117-06
Ranitidine tablets, USP 150mg- acid reducer (Walmart)150 mg24’s Bottle49035-100-00
Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)150 mg200’s Bottle0363-1030-07
ProductStrengthPack SizeNDC Number
Ranitidine tablets, USP 150 mg – acid reducer (Rite Aid)150 mg24’s Bottle11822-6051-8
Ranitidine tablets, USP 150mg- acid reducer (Walmart)150 mg130’s Bottle49035-100-07
Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)150 mg24’s Bottle0363-1013-02
Wal-Zan® 75 RANITIDINE TABLETS, USP 75 mg / ACID REDUCER (WALGREENS)75 mg30’s Bottle0363-1029-03
Cool mint Ranitidine tablets, USP 150 mg – acid reducer (Rite Aid)150 mg24’s Bottle11822-6107-4
Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)150 mg65’s Bottle0363-1030-06
Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)150 mg95’s Bottle0363-1030-09

Sandoz Inc. list:

Product NameNDC NumberLot Nbr.Expiration DateDate of Manufacture
RANITIDINE 150mg Capsules 500 count0781-2855-05HD18624/30/20204/19/2017
RANITIDINE 150mg Capsules 500 count0781-2855-05HP94389/30/20209/5/2017
RANITIDINE 150mg Capsules 500 count0781-2855-05HP94399/30/20209/6/2017
RANITIDINE 150mg Capsules 500 count0781-2855-05HP94409/30/20209/5/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60HC92664/30/20204/19/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60HD18654/30/20204/19/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60HP94419/30/20209/6/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60JK79948/31/20218/7/2018
RANITIDINE 150mg Capsules 60 count0781-2855-60JK86598/31/20218/7/2018
RANITIDINE 300mg Capsules 30 count0781-2865-31HD86254/30/20204/27/2017
RANITIDINE 300mg Capsules 30 count0781-2865-31HD92754/30/20204/27/2017
RANITIDINE 300mg Capsules 30 count0781-2865-31HU22078/31/20208/24/2017
RANITIDINE 300mg Capsules 30 count0781-2865-31HX66763/31/20213/20/2018
RANITIDINE 300mg Capsules 30 count0781-2865-31HX66773/31/20213/20/2018

Fisher-Price Recalls Inclined Sleeper Accessory Included with Ultra-Lite Day & Night Play Yards Due to Reports of Infant Fatalities

Fisher Price is recalling their inclined sleeper accessory included with all models of Fisher-Price Ultra-Lite Day & Night Play Yards due to reports of infant fatalities being reported from use of other inclined sleep products, after the infants rolled from their back to their stomach or side while unrestrained, or under other circumstances. Approximately 71,000 units are being recalled.

Papaya “Caribeña”, Recalled Due to Salmonella

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.

Grande Produce has announced a voluntary recall of a limited quantity of Papaya Maradol (with the brand name Caribeña labeled on cartons) distributed during the dates of July 10 and July 19 due to a potential health risk from Salmonella.

According to Grande Produce, a Maryland distribution center where the papayas were delivered has already notified retail customers to remove the recalled papayas from inventories, store shelves and the stream of commerce.  Recall effectiveness checks are already underway by Grande Produce.

The only papayas subject to the recall carry a “Caribeña” brand label on cartons and were shipped during the dates of July 10 to July 19.  No other papayas or fresh produce distributed by Grande Produce are subject to the recall.

Grande Produce has ceased importation of papayas from the grower and is taking all precautionary measures to ensure the safety of its imported produce.  The company is also coordinating closely with the U.S. Food and Drug Administration and other regulatory agencies in their investigations and will provide any assistance possible. 

Environmental microbial testing conducted by Grande Produce of its facilities has been negative for the Salmonella organism to-date.   Specific sources of what health officials now believe maybe two separate Salmonella outbreaks have not yet been determined.  Of the 47 cases reported nationally, five illnesses are currently reported in the State of Maryland where Grande Produce distributed product. 

15-Inch MacBook Pro Laptop Computers Recalled Due to Fire Hazard

This recall involves certain Apple 15-inch MacBook Pro laptop computers. The recalled laptop computer specs are as follows:

  • a 15.4-inch display,
  • 2.2-2.5 GHz processors,
  • 256GB – 1TB solid-state storage
  • two Thunderbolt 2 ports
  • two USB 3 ports
  • one HDMI port

Consumers can determine if their laptop computer is included in this recall by checking the laptop’s serial number at https://support.apple.com/15-inch-macbook-pro-battery-recall/.

The serial number can be found on the underside of the laptop computer or by choosing “About This Mac” from the Apple menu. Only MacBook Pro 15-inch model laptop computers with certain serial numbers are included.