A recall has been initiated for bottles of generic Pravachol, a cholesterol drug frequently prescribed to children, after finding that some bottles may contain generic versions of the antidepressant Wellbutrin, which could cause serious adverse health effects if mistakenly consumed.
The FDA announced the generic Pravastatin recall on August 9, after a pharmacy reported finding a bottle containing generic Wellbutrin. To date, no injuries or hospitalizations have been reported in relation to the recall.
The recall involves Prevastatin Sodium Tablets USP 40 mg, which were distributed in bottles of 30 tablets. The medication is a type of statin known as a HMG-CoA reductase inhibitor used to lower cholesterol. It is approved for treatment of patients ages 8 and older and is often prescribed to children with cholesterol problems.
The generic Wellbutrin medication that mistakenly entered the bottles are bupropion hydrochloride extended-release tablets (XL) 300 mg, which are an aminoketone antidepressant used to treat major depressive disorders and to prevent seasonal affective disorders in children, adolescents, young adults, and adults.
In the event an individual mistakenly takes generic bupropion, they could experience nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness and blurry vision. Although the side effects are minor and quickly reversible, individuals with epilepsy or using other medications could have risky drug interactions or higher risk of seizures, posing serious and potentially life-threatening side effects.
The mislabeled bupropion hydrochloride tablets were manufactured by International Laboratories LLC of St. Petersburg, Florida, where they were delivered to distribution centers in Arkansas, Georgia and Indiana for distribution 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 has begun notifying its distributors and customers by letter with instructions to not open the package or consume the contents, and to return the package to the location of purchase for a full refund.
Consumers who are in possession of the recalled medication should stop consuming it immediately and contact their healthcare provider. Customers with questions regarding the recall are being asked to contact International Laboratories LLC by phone at 727-322-7146 or email them at [email protected] Individuals experiencing adverse health consequences are consumption of the recalled medications should contact their healthcare physicians immediately.