International Laboratories, LLC has issued a recall for one lot of Pravastatin Sodium Tablets 40mg packaged in 30-count bottles (NDC# 54458-925-16; Lot # 115698A) due to mislabeling.
The Company states that the product is labeled as Pravastatin Sodium Tablets 40mg but contains Bupropion HCl XL 300mg Tablets. Pravastatin, an HMG Co-A reductase inhibitor, is indicated for the treatment of primary hyperlipidemia and mixed dyslipidemia while bupropion HCl XL, an aminoketone, is used for the treatment of major depressive disorder and prevention of seasonal affective disorder.
While side effects of bupropion are typically minor, some patients may be at greater risk for adverse effects. Patients with epilepsy may be at greater risk for seizure as bupropion can lower the seizure threshold. In addition, patients on MAOIs may be at increased risk for hypertensive crisis if the drugs are taken concomitantly. Allergic reactions to bupropion are also be possible in some patients.
At this time, the Company has not received any reports of medical illness or harmful effects as a result of the mislabeled product.
The product was 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.
Individuals with questions regarding this recall can call International Laboratories at (727) 322-7146 or email [email protected].
For more information visit Internationallabs.com.