Pravastatin/Bupropion Mix-Up Leads to Recall
One lot of pravastatin tablets (40 mg, 30-tablet bottles) has been recalled due to the bottles being filled with tablets of bupropion. International Laboratories, LLC is voluntarily recalling the lot.
The product in question is labeled Prevastatin Sodium Tablets USP 40 mg, but instead contained Bupropion Hydrochloride XL 300 mg tablets. The affected product is NDC# 54458-925-16; Lot# 115698A.
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Common side effects of mistakenly taking bupropion include nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, and blurry vision. Individuals with epilepsy are also at greater risk for seizure, and individuals on MAOIs could have a risky drug interaction with bupropion.
International Laboratories, LLC is notifying customers by letter and arranging return of the products.
—Michael Potts
Reference:
Pravastatin sodium tablets by International Laboratories: recall – mislabeling. FDA. August 10, 2017.https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm571066.htm.