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The FDA Sends a Warning Letter to Fresenius Regarding Granuflo and NaturaLyte

On September 15, 2010, an FDA Warning Letter was sent to Fresenius’s CEO after an investigation into the Fresenius facilities and procedures that lasted from June 15, 2010, through August 6, 2010. It addressed the facility’s lack of adequate procedures in dealing with complaints associated with NaturaLyte Acid Concentrate products. The letter offers some insight into the events leading to the FDA recall for Granuflo (powder) Acid Concentrate and NaturaLyte Liquid Acid Concentrate.

The letter points to insufficient procedures concerning the reporting of incidents and the safety of products. For instance, it specifically points to a 2007 incident in which a patient suffered a “symptomatic hypocalcemia with parethesias and tetani” after using the wrong mount of the NaturaLyte substance, also indicating that the patient had once before been sent the wrong dosage.

A subsequent inquiry into this complaint indicated several other complaints concerning NaturaLyte products between January 2007 and July 2010. The letter also noted that Fresenius did not sufficiently verify that labeling revisions would help prevent product mix-ups, and that Fresenius also failed to establish sufficient procedures for evaluating complaints.

Recalls of Granuflo and NaturaLyte

On June 27, 2012, in light of the numerous instances of Fresenius dialysis injury, the FDA issued the recalls of Granuflo and NaturaLyte.

Such products are popular treatment options for dialysis patients in the United States. However, an investigation by the FDA showed that the products were linked to at least 941 instances of cardiac arrest, and put patients at risk of death resulting from Granuflo and NaturaLyte.

Fresenius failed to warn the consuming public of issues associated with the products for four months after company representatives learned of the dangers, which the FDA discovered after receiving an anonymous internal Fresenius memo concerning a high risk of injury associated with Granuflo and NaturaLyte.

Five specific areas cited in Fresenius’s failures

The FDA’s letter delineates five specific areas in which the laboratory failed to adequately maintain procedures in accordance with the Code of Federal Regulations.

Specifically, the letter cited the following:

• Failure to establish and maintain proper procedures for implementing corrective actions in light of a complaint linked to commercial distribution of Liberty Cassettes

• Failure to establish procedures for investigating the cause of nonconformities stemming from incidents pertaining to NaturaLyte Acid Concentrate

• Failure to establish and maintain an adequate preventative action to ensure identification of actions needed to corrects and prevent problems

• Failure to establish procedure for receiving, reviewing, and evaluating complaints

People are determining eligibility to file a lawsuit

In light of the recall, many people are now coming forth to determine whether they’re eligible to file a NaturaLyte and Granuflo lawsuit, citing Fresenius’s negligence in its failure to warn of the dangers associated with the products. According to several news reports, hundreds of thousands of people in the United States may have been exposed to the dangers of NaturaLyte and Granuflo.

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