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Recalls That Should Be On Your Radar—Week of December 30, 2018

JAN 05, 2019 | CONTAGION® EDITORIAL STAFF
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:

Food Safety Recalls:

Oskri Organics Corporation Recalls Sunflower and Tahini Butter Due to Potential Contamination with Listeria Monocytogenes

Oskri Organics Corporation of Lake Mills, WI is recalling Oskri Organic Sunflower Butter Lot # 099, Oskri Tahini Butter LOT # 193 and Thrive Sunflower Butter LOT # 233, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

No illnesses have been reported to date.

On 12/18/18 we were informed by one of our customers that they randomly sent our product in for testing, it came back positive for Listeria monocytogenes. An investigation is still ongoing to find the source of the Listeria monocytogenes. We have ceased the production and distribution of the product as FDA and Oskri continue their investigation as to what caused the problem.

To read more about this recall, check out the company’s statement.

R. L. Zeigler Co., Inc. Recalls Chicken and Pork Products due to Possible Contamination with Metal

R. L. Zeigler Co., Inc., a Selma, Ala. establishment, is recalling approximately 11,664 pounds of ready-to-eat (RTE) poultry and meat sausage products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The RTE Red Hot chicken and pork sausage items were produced on Nov. 29, 2018. 

The products subject to recall bear establishment number “EST. P-9156S” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.

The problem was discovered after the firm received consumer complaints on Dec. 13 and 27, 2018. The firm investigated to determine the nature of the complaints and notified FSIS on Dec. 29, 2018.  

For details about the affected products, read the USDA’s news release.

Medical Device Recalls:

Results RNA LLC Recalls Lubrisine Eye Drops Due to Sterility Concerns

Results RNA LLC is voluntarily recalling Lubrisine Eye Drops to the healthcare practitioner, retail or consumer level. This product, in a recent FDA inspection, was found to be manufactured using practices that do not support its sterility and contained undeclared colloidal silver.

Use of a non-sterile eye drop could result in a potentially sight threatening eye infection. Exposure to colloidal silver, over an extended period of time, could result in permanent discoloration of the conjunctiva. Results RNA has not received any reports of adverse events related to this recall. No illnesses have been reported regarding the product to date. The products can be identified by the following label and the lot number located on the bottom of the bottle.

The product is used to support lubrication of dry eyes and is packaged in a single 1oz dropper bottle with the UPC code 9238230723. The affected Lubrisine Eye Drops lots include all lots manufactured from May 12, 2012 forward. This date of manufacture is located on the bottom of the bottle.

To learn more about this recall, consult the company’s statement.

Torrent Pharmaceuticals Limited Expands Losartan Potassium Tablet Recall

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

NDEA 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.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
For details on the recall check out the recall notice.

Aurobindo Pharma USA, Inc. Recalls Valsartan Tablets due to Presence of NDEA Impurity

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP 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.

To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

For a complete list of affected lots, consult the recall statement.
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