Crystallization Prompts Recalls of Tissue Softeners

The US Food and Drug Administration (FDA) announced two recalls of medications used to soften tissue.

What prompted the Class III recall? The manufacturer, Sonar Products Inc. of New Jersey, received complaints that the cream had crystallized.

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More than 20,000 tubes of Remeven cream (50% urea in a cream base) are being recalled by Stratus Pharmaceuticals Inc. of Florida.

More than 6,300 tubes of urea (50% urea in a cream base) are being recalled by Exact-Rx Inc. of New York.

The impacted products were distributed nationwide and in Puerto Rico.

--Stephanie Vaccaro

Reference:

US Food and Drug Administration. FDA Enforcement Report – Week of August 31, 2016. www.fda.gov. Accessed August 31, 2016.