Jessy Edwards  |  March 28, 2022

Category: Legal News

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Plastikon recall milk of magnesia and acetaminophen
(Photo Credit: U.S. Food and Drug Administration)

Plastikon Milk of Magnesia, Acetaminophen, Magnesium Hydroxide Reall:

  • Who: Plastikon Healthcare, LLC is recalling lots of milk of magnesia, acetaminophen and magnesium hydroxide/aluminum hydroxide/simethicone.
  • Why: The products are being recalled due to microbial contamination and failure to properly investigate failed microbial testing.
  • Where: The products were distributed nationwide.

A pharmaceutical company is recalling 10 lots of various medications that were distributed to hospitals and nursing homes nationwide to treat constipation, sour stomach and aches and pains.

Plastikon Healthcare issued a recall notice due to microbial contamination on the U.S. Food & Drug Administration website Mar. 24 for three lots of milk of magnesia, one lot of acetaminophen and six lots of magnesium hydroxide 1200mg/aluminum hydroxide 1200mg/simethicone 120mg.

“The products are being recalled due to microbial contamination and failure to properly investigate failed microbial testing,” the company said. 

The recall says that the products are packaged for institutional use. The distributor, Major Pharmaceuticals, shipped the product to hospitals, nursing homes and clinics nationwide. 

According to the recall notice, consuming the products could potentially result in illness due to intestinal distress, such as diarrhea or abdominal pain.  

People with a compromised immune system have a higher probability of developing a widespread, potentially life-threatening infection when ingesting or otherwise orally exposed to products contaminated by microorganisms, the recall notice says. 

Recalled Plastikon Products Should Be Quarantined, Returned

The affected lots, which are packaged in single-use cups with a foil lid, were distributed between Mar. 1, 2020 and June 28, 2021. The affected products’ lot numbers and expiration dates can be found here

Plastikon has not received any customer complaints related to microbial concerns or reports of adverse events related to this recall so far, it said. 

The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.

“Plastikon Healthcare has notified its direct customers via a recall letter to arrange for return of any recalled product,” it said. “Anyone with an existing inventory of the lots which are being recalled should stop use and distribution, and quarantine immediately.”

The quarantined products should be returned to the places of purchase, and clinics, hospitals or health care providers that have dispensed products to patients should notify patients of the recall, Plastikon said.

Meanwhile, Pfizer is recalling 11 lots of hypertension medications distributed by itself and by the company Greenstone, as it contains too much of the carcinogenic chemical compound nitrosamine. Click here for more details

What do you think of this nationwide recall? Let us know in the comments!


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