Antidepressants Mislabeled As Sodium Recalled; Serious Injury

On August 10, 2017, International Laboratories, LLC, recalled one lot of Pravastatin Sodium Tablets USP 40 mg due to mislabeling. The product was labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets.


If a subject mistakenly takes bupropion, common side effects include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, and blurry vision. These are typically minor and reversible issues. However, individuals with epilepsy are at higher risk of seizure on bupropion due to it lowering the seizure threshold. Also, people on monoamine-oxidase inhibitor (MAOIs) can have a risky drug interaction with bupropion (hypertensive crisis). Finally, allergic reactions are also possible and could be life threatening.


Pravastatin Sodium Tablets USP 40 mg are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. It is used to treat children and adolescent patients ages eight years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.


Bupropion hydrochloride extended-release tablets (XL) 300 mg are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD) in children, adolescents, young adults and adults.


The recalled product has NDC number 54458-925-16 and Lot number 115698A. It is packaged in bottles of 30 tablets.


See the FDA Safety Alert


See the Recall


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