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

D-0102-2018

August 07, 2017

Class I

Product summary

Firm: International Laboratories, Inc.
Event: Event 77899
Status: Terminated
Classification: Class I
Quantity: 82056 bottles
Official record key: drug-enforcement:D-0102-2018

Official wording

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

Code information: Lot # 115698A, Exp 02/19

Distribution pattern: U.S.A. nationwide and Puerto Rico

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

Labeling: Label mix-up