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FDAApril 25, 2024drug

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

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

The hazard

Presence of Particulate Matter: Potential for black particulates in the drug product.

What to do

FDA enforcement status: Ongoing

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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MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10 — Recall Details · AllClear