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Exela Pharma Sciences LLC — ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
Presence of Particulate Matter: Silicone
The Recall Registry rates this highest risk — FDA Class I: reasonable probability of serious harm or death.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: Exela Pharma Sciences LLC
The product
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).
Details
- Units affected
- 38,200 vials
- Recall date
- October 18, 2023
- Brand
- Exela Pharma Sciences LLC
Nationwide
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “Exela Pharma Sciences LLC — 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, Lenoi”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine