FDA Recalls You Should Know About—Week of May 20, 2018


In case you missed them, we’ve compiled a list of the latest recalls posted this week.

We’ve rounded up a list of recalls issued by the US Food and Drug Administration (FDA) that you should know about. Take a look:

Drops, Syrup, Spray, & Elixir Recalled Due to Lack of Adequate Controls

MBI Distributing, Inc. has issued a voluntary recall for all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir down to the consumer level due to lack of adequate controls.

Without proper process controls, there is a higher probability that the products will vary in strength, quality, and purity. As such, if used, these products could potentially result in adverse reactions, especially in populations that are particularly vulnerable. However, no such events have been reported thus far.

The recalled products are packaged in sizes from 1 fluid ounce to 8 fluid ounces.

For more information, be sure to check out the official safety alert.

HeartMate 3 Left Ventricular Assist System Recalled Due to Potential Malfunction

The FDA has issued a class I recall of the HeartMate 3 Left Ventricular Assist System due to a malfunction in the device’s outflow graft assembly that could potentially result in graft occlusion. Graft occlusion could reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump flow could result in serious adverse events such as blood clots and death.

For more information, be sure to check out the official press release.

95% Ethyl Alcohol Product Recalled Due to Potential Methanol Contamination

The Lake Michigan Distilling Company, LLC, or Ethanol Extraction, has issued a recall for its 95% Ethyl Alcohol product due to potential contamination with methanol, which could result in serious, potentially life-threatening damage if ingested by humans or animals.

Sold through the company’s website, the recalled products—sold in different sized bottles ranging from 8 oz to 1 gallon and 2.5 gallon and 5-gallon containers—were delivered throughout the United States.

For more information, check out the official company announcement.

Stolen Frozen Tilapia Recalled Due to Potential Salmonella Contamination

Golden International Corporation issued a public safety notice for 405 cartons of stolen frozen tilapia due to potential Salmonella contamination. As such, the company is warning consumers, food distributors, grocery stores, and food processors to refrain from consuming or selling certain cartons of stolen tilapia.

The product, which was ready to re-export to Taiwan, had been stolen from the company yard based in Renton, Washington around 4:40 PM on Sunday, April 29, 2018; it was recovered in Everett, Washington on May 9, 2018. It is suspected that the product was sold by thieves in the surrounding area and maybe beyond.

After undergoing routine sampling, Salmonella was detected.

For more information, be sure to read the official announcement.

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