FDA.gov – Class I Recall – Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling.
Cook Medical has identified that an error occurred during manufacturing which may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014” wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018” wire guides). Marker bands that are too loose can dislodge from their original position and marker bands that are too tight can cause buckling.
The CrossCath® Support Catheters are designed to support a wire guide during access of blood vessels, allow for an exchange of wire guides, and provide a pathway for the delivery of saline solutions or diagnostic contrast agents. The catheters have three radiopaque markers spaced equally along the catheter to aid in estimating lengths within the blood vessels (vascular system).
Possible plastic contamination has forced Ruiz Food Product’s El Monterey to recall tons of their Signature Egg, Sausage and Cheese frozen breakfast burritos. The burritos are sold in 3.38-pound packages and contain 12 individually wrapped.
For more information, you can contact us or visit our various social media.
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.
Med 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:
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.
|Product||Strength||Pack Size||NDC Number|
|Ranitidine tablets, USP 150mg- acid reducer (Rite Aid)||150 mg||50’s Bottle||11822-6052-1|
|Ranitidine tablets, USP 150mg- acid reducer (Rite Aid)||150 mg||65’s Bottle||11822-6052-2|
|Ranitidine tablets, USP 150mg- acid reducer (Rite Aid)||150 mg||95’s Bottle||11822-4727-3|
|Ranitidine tablets, USP 150mg- acid reducer (Walmart)||150 mg||65’s Bottle||49035-117-06|
|Ranitidine tablets, USP 150mg- acid reducer (Walmart)||150 mg||24’s Bottle||49035-100-00|
|Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)||150 mg||200’s Bottle||0363-1030-07|
|Product||Strength||Pack Size||NDC Number|
|Ranitidine tablets, USP 150 mg – acid reducer (Rite Aid)||150 mg||24’s Bottle||11822-6051-8|
|Ranitidine tablets, USP 150mg- acid reducer (Walmart)||150 mg||130’s Bottle||49035-100-07|
|Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)||150 mg||24’s Bottle||0363-1013-02|
|Wal-Zan® 75 RANITIDINE TABLETS, USP 75 mg / ACID REDUCER (WALGREENS)||75 mg||30’s Bottle||0363-1029-03|
|Cool mint Ranitidine tablets, USP 150 mg – acid reducer (Rite Aid)||150 mg||24’s Bottle||11822-6107-4|
|Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)||150 mg||65’s Bottle||0363-1030-06|
|Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)||150 mg||95’s Bottle||0363-1030-09|
Sandoz Inc. list:
|Product Name||NDC Number||Lot Nbr.||Expiration Date||Date of Manufacture|
|RANITIDINE 150mg Capsules 500 count||0781-2855-05||HD1862||4/30/2020||4/19/2017|
|RANITIDINE 150mg Capsules 500 count||0781-2855-05||HP9438||9/30/2020||9/5/2017|
|RANITIDINE 150mg Capsules 500 count||0781-2855-05||HP9439||9/30/2020||9/6/2017|
|RANITIDINE 150mg Capsules 500 count||0781-2855-05||HP9440||9/30/2020||9/5/2017|
|RANITIDINE 150mg Capsules 60 count||0781-2855-60||HC9266||4/30/2020||4/19/2017|
|RANITIDINE 150mg Capsules 60 count||0781-2855-60||HD1865||4/30/2020||4/19/2017|
|RANITIDINE 150mg Capsules 60 count||0781-2855-60||HP9441||9/30/2020||9/6/2017|
|RANITIDINE 150mg Capsules 60 count||0781-2855-60||JK7994||8/31/2021||8/7/2018|
|RANITIDINE 150mg Capsules 60 count||0781-2855-60||JK8659||8/31/2021||8/7/2018|
|RANITIDINE 300mg Capsules 30 count||0781-2865-31||HD8625||4/30/2020||4/27/2017|
|RANITIDINE 300mg Capsules 30 count||0781-2865-31||HD9275||4/30/2020||4/27/2017|
|RANITIDINE 300mg Capsules 30 count||0781-2865-31||HU2207||8/31/2020||8/24/2017|
|RANITIDINE 300mg Capsules 30 count||0781-2865-31||HX6676||3/31/2021||3/20/2018|
|RANITIDINE 300mg Capsules 30 count||0781-2865-31||HX6677||3/31/2021||3/20/2018|