Drug Safety Alerts

Pravastatin sodium 40 mg tablets Consumer-level Recall

8/10/2017

On August 10, 2017, the United States Food and Drug Administration (FDA) issued a MedWatch regarding a consumer-level recall of pravastatin sodium 40 mg tablets distributed by International Laboratories. This recall was issued due to mislabeling. One bottle of pravastatin sodium 40 mg tablets was mislabeled and contained bupropion hydrochloride XL 300 mg tablets.

This recall affects lot number 115698A. No other lots are affected by this recall.

If a patient mistakenly takes bupropion, common side effects include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. These are typically minor and reversible issues. However, individuals with epilepsy are at higher risk of seizure on bupropion due to it lowering the seizure threshold. Also, people on MAOIs can have a risky drug interaction with bupropion (hypertensive crisis). Finally, allergic reactions are also possible and could be life threatening.

This lot of Pravastatin Sodium Tablets USP 40 mg was recalled when International Laboratories, LLC was informed by a pharmacist that one 30ct bottle of this product was mislabeled and contained Bupropion Hydrochloride XL 300 mg tablets. International Laboratories, LLC has reported that no complaints or reports of medical illnesses or harmful effects have been received to date.

Pravastatin sodium 40 mg tablets are light-green, round-shaped tablets with “TEVA” on one side and 7202 on the other.

International Laboratories, LLC is notifying its distributors and customer by letter and is arranging for return of all recalled products.  Consumers who have purchased this product should not open the package or use the contents. Instead, they should return the product to the location of purchase for a full refund.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about the [action taken], please contact International Laboratories at 727-322-7146, Monday through Friday, 8:00 am to 5:00 pm (ET) or visit www.internationallabs.com.

You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.