Recalls

Statin recalled due to labeling mixup

ucm571034 375x181 Statin recalled due to labeling mixup International Laboratories LLC is recalling one lot of pravastatin tablets, a generic version of the cholesterol-lowering statin Pravachol, because the bottle may contain bupropion, a generic version of the antidepressant Wellbutrin. This labeling mixup could cause a patient to suffer potential serious side effects.

For example, someone who mistakenly takes bupropion could experience nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness and blurry vision. These are typically minor and reversible side effects. But people with epilepsy are at higher risk of seizure on bupropion because it lowers the seizure threshold.

Also, people taking MAOIs can have a risky drug interaction with bupropion, called a hypertensive crisis. Allergic reactions are also possible and could be life-threatening.

International Laboratories LLC was informed by a pharmacist that one bottle of pravastatin sodium tablets USP 40 mg packaged in bottles of 30 tablets contained bupropion hydrochloride XL 300 mg tablets. No adverse events have been reported to date.

Pravastatin sodium tablets are an HMG-CoA reductace inhibitor, or statin, and are used to lower cholesterol in patients when a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone have not been adequate. It is used to treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.

Bupropion hydrochloride extended-release (XL) tablets 300 mg are an aminoketone antidepressant used to treat major depressive disorder (MDD) and prevent seasonal affective disorder (SAD) in children, adolescents, young adults and adults.

Affected tablets were delivered to distribution centers in Arkansas, Georgia and Indiana and distributed to retail stores in Arkansas, Alabama, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, Ohio, Oklahoma, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia and Wisconsin.

International Laboratories LLC is notifying its distributors and arranging for return of all recalled products. Consumers with affected products should return the tablets to where they were purchased, or call International Laboratories LLC at 727-322-7146.

Any adverse events should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA Recall Notice