FDAFDA · Food and drugs·Recall number D-0102-2018
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
Published December 13, 2017 · Recall initiated: August 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- International Laboratories, Inc.
- Distributor
- U.S.A. nationwide and Puerto Rico
- Lot
- Lot # 115698A, Exp 02/19
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.