Ranitidine Recalls

Ranitidine Tablets, 150mg and 300mg, and Ranitidine Syrup (Oral Solution), 15 mg/mL by Amneal Pharmaceuticals:

Recall – Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity.

ranitidine_tablets_recall ranitidine_syrup_recalled

Up2 by Med Man Distribution: Recall

up2_by_med_manMed Man Distribution is voluntarily recalling its supplement, UP2. The dietary supplement, advertised for its lebido enhancing abilities in men and women, has been found to contain amounts of Sildenafil, which is an FDA-approved prescription drug for erectile dysfunction. Med Man Distribution does not have approval to distribute Sildenafil, thus warranting a full recall of all UP2.

The affected Up2 Dietary supplement lots include:

  • 240 ten count units upc is 85606300322
  • 480 four count packages upc 856063006315
  • 960 singlepack units upc 856063006308.

Up2 was distributed in the USA to Regal Labs and to their nationwide retailers. To date, Med Man has not received any reports of adverse events related to this recall.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

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.