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FDAApril 30, 2019drug

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02

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

The hazard

Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

What to do

FDA enforcement status: Terminated

Brands named

sagent pharmaceuticalssagent

Recall history

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

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