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FDAOctober 18, 2023drug

ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).

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

The hazard

Presence of Particulate Matter: Silicone

What to do

FDA enforcement status: Ongoing

Brands named

exela pharma sciencesexelaexela pharma

Recall history

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

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