International Laboratories LLC is recalling one lot of bottles labeled pravastatin sodium tablets 40 mg. The bottles actually contain 300-mg tablets of bupropion hydrochloride. The affected product is NDC# 54458-925-16; Lot# 115698A.
The recall is a voluntary one. The error was called to the attention of International Laboratories by an alert pharmacist.
Pravastatin is a cholesterol-lowering agent. Bupropion is an antidepressant. Taking 300 mg of bupropion could cause side effects such as nausea, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, and blurry vision, and can increase the risk of seizure in people with epilepsy. People on MAOIs could suffer a hypertensive crisis with bupropion.
International Laboratories is notifying its distributors and customers about the recall by letter and is arranging for return of the product.
Health-care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.