FDA recall D-0102-2018

International Laboratories, Inc. · Class I · drug

Product

Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16

Reason for recall

Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.

Distribution

U.S.A. nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2017-08-07
Report date: 2017-12-13
Termination date: 2019-05-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: St Petersburg, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0102-2018