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
Product summary
- 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
Labeling: Label mix-up