International Laboratories has initiated a voluntary nationwide recall of a single lot of pravastatin sodium USP 40-mg tablets because it is mislabeled and instead contains the antidepressant bupropion, an FDA MedWatch safety alert notes[1].
On August 9, 2017 the drug maker recalled to consumer level one lot of pravastatin sodium tablets—40-mg, 30-count bottle, NDC 54458-925-16, lot 115698A—after a pharmacist alerted the company that one bottle of the drug was mislabeled and contained bupropion hydrochloride extended-release 300-mg tablets, according to the alert, posted August 10, 2017 by the FDA.
If an individual mistakenly takes buproprion, side effects are typically minor and reversible and include nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, and blurry vision.
Individuals with epilepsy, however, are at higher risk of seizure on bupropion because it lowers the seizure threshold, the safety alert adds.
Those on monoamine oxidase inhibitors (MAOIs) are at risk of having a hypertensive crisis with bupropion, it also notes. Allergic reactions are also possible and could be life-threatening.
No complaints or reports of illness have been reported, according to a company news release[2].
Pravastatin, an HMG-CoA reductase inhibitor, or statin, is used to lower blood cholesterol in adults and to treat heterozygous familial hypercholesterolemia in children and adolescents ages 8 years and older.
Bupropion is indicated for the treatment of major depressive disorder and prevention of seasonal affective disorder.
Distributors and customers have been asked to return the recalled product, which was sent to distribution centers in Arkansas, Georgia, and Indiana and distributed to retail stores in Arkansas, Alabama, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North and South Carolina, North and South Dakota, Nebraska, Ohio, Oklahoma, Puerto Rico, Tennessee, Texas, Virginia, and Wisconsin.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of the product to the FDA's MedWatch Safety Information and Adverse Event Reporting program.
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Medscape Medical News © 2017
Cite this: Pravastatin Tablets Recalled, Contain Antidepressant - Medscape - Aug 11, 2017.
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