ELCYS cysteine hydrochloride injection recalled for silicone contamination
Exela Pharma Sciences is recalling 38,200 vials of ELCYS (cysteine hydrochloride injection) nationwide due to the presence of silicone particulate matter.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of Severe per the rubric. Silicone particulate matter in an intravenous injection poses a direct risk to patient safety; no reported illnesses or hospitalizations are documented in the source.
Plain-English summary
ELCYS (cysteine hydrochloride injection), 500 mg/10 mL in single-dose sterile vials, is being recalled by Exela Pharma Sciences LLC. The affected lot is #10000798 with an expiration date of 03/31/2025. This lot comprises 38,200 vials that were distributed nationwide.
The recall was initiated due to the presence of silicone particulate matter detected in the product. Silicone particles in an intravenous injection pose a direct safety risk to patients.
Healthcare providers and facilities that received the affected lot should immediately stop using it and quarantine all remaining vials from lot #10000798. Patients who may have received injections from this lot should consult their healthcare provider. The FDA classified this as a Class I recall, indicating a serious potential hazard.
The recalled product
- Product
- ELCYS (CYSTEINE HYDROCHLORIDE)
- Brand
- ELCYS
- Manufacturer
- Exela Pharma Sciences LLC
- Category
- Drug — Intravenous injection
- Hazard
- silicone
- particulate-matter
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 10000798
- Expiration Date 03/31/2025
Distribution
Distributed nationwide across the United States.
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