Class I
Terminated
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
- Company
- International Laboratories, Inc.
- Recall Initiated
- August 7, 2017
- Posted
- December 13, 2017
- Recall Number
- D-0102-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 82056 bottles
- Firm Location
- St Petersburg, FL, United States
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
Lot / Code Info
Lot # 115698A, Exp 02/19
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