Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
Reported: December 13, 2017 Initiated: August 7, 2017 #D-0102-2018
Product Description
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.
Details
- Recalling Firm
- International Laboratories, Inc.
- Units Affected
- 82056 bottles
- Distribution
- U.S.A. nationwide and Puerto Rico
- Location
- St Petersburg, FL
Frequently Asked Questions
What product was recalled? ▼
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16. Recalled by International Laboratories, Inc.. Units affected: 82056 bottles.
Why was this product recalled? ▼
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 13, 2017. Severity: Critical. Recall number: D-0102-2018.
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