Recalls That Should Be on Your Radar—Week of March 3, 2019

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Sunstone Organics Issues Recall for Some Kratom Product Potentially Contaminated with Salmonella

Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella.

Risk Statement: The product potentially could result in contracting salmonella. Symptoms of salmonella can include illness, vomiting, and some cases even death. This risk is higher for users a compromised or weak immune system, including elderly and young children. Sunstone Organics has not received any reports of adverse events to date related to this recall.

Learn more about the recall here.

Apotex Corp. Issues Recall of Drospirenone and Ethinyl Estradiol Tablets Duet to Incorrect Tablet Arrangement

Weston, Florida, Apotex Corp . is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.

Risk Statement : As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or that a patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage consumed. To date, no case has been reported for pregnancy and adverse event to Apotex.

More information on this recall can be found here.

McDaniel Life-Line Issues Recall of Life-Line Water Potentially Contaminated With Pseudomonas Aeruginosa

McDaniel Life-Line LLC is voluntarily recalling all lots of Life-Line Water to the consumer level. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa.

Use of the contaminated product has a remote probability of necessitating medical or surgical intervention to preclude or reverse permanent damage to a body structure or function. To date, McDaniel Life-Line LLC has not received any reports of adverse events related to this recall.

Additional details on this recall can be found here.

American Health Packaging Issues Recall of Valsartan Tablets Due to Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging.

Learn more about this Valsartan recall here.

Washington Beef, LLC Issues Recall for Ground Beef Potentially Contaminated With Foreign Matter

Washington Beef, LLC, a Toppenish, Wash. establishment, is recalling approximately 30,260 pounds of ground beef chubs products that may be contaminated with extraneous materials, specifically hard plastic and metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ground beef chubs were produced on Dec. 27, 2018 and include a “Use or Freeze by” date of 01/20/19.

Additional information on this recall can be found here.