February 06, 2017
More than 2500 bottles of Dexamethasone Elixir, USP, 0.5 mg/5 mL have been pulled from the US market.
The US Food and Drug Administration (FDA) lists the reason for the recall as “Failed Impurities/Degradation Specifications” in the Enforcement Report for the week of February 1, 2017 (http://bit.ly/1WfaCbN).
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The recall affects bottles distributed nationwide from lot number 0000007104 (Exp 05/17). The medication, which is indicated for the treatment of a several conditions (eg, endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases), is packaged in 8 fl oz bottles.
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals voluntarily initiated the recall on January 16, 2017. It is currently in progress.
The FDA gave the recall a Class III designation on January 24, 2017. Class III recalled products are those that “are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws,” according to the FDA Enforcement Report Definitions page.—Meredith Edwards White