FDA-Drug2017-12-13Class I
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
International Laboratories, Inc.
Hazard
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Sold states
U.S.A. nationwide and Puerto Rico
Affected count
82056 bottles
Manufactured in
2701 75th St N, N/A, St Petersburg, FL, United States
Products
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0102-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief