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FDAJanuary 12, 2018drug

Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.

What to do

FDA enforcement status: Terminated

Brands named

international laboratoriesinternational

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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