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

FDA recall notice · announced December 13, 2017 · International Laboratories

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: U.S.A. nationwide and Puerto Rico
Lot/code information: Lot # 115698A, Exp 02/19
Quantity: 82056 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.