CYSTEINE HYDROCHLORIDE Recall D-0118-2024
Description: 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).
CYSTEINE HYDROCHLORIDE Recall D-0118-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0118-2024 |
| Event ID | 93265 |
| Brand | ELCYS |
| Generic Name | CYSTEINE HYDROCHLORIDE |
| Manufacturer | CYSTEINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | CYSTEINE HYDROCHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide |
| Quantity | 38,200 vials |
| Recall Reason | Presence of Particulate Matter: Silicone |
| Drug Classification | Class I |
| Drug Code Info | 20231129 |
| Product NDC | 51754-1007 |
| Recall Initiation Date | 20231018 |
| Report Date | 20231129 |
| Classification Date | 20231122 |
| Address | 1245 Blowing Rock Blvd Lenoir, NC 28645-3618 United States |
| Recalling Firm | Exela Pharma Sciences LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | ZT934N0X4W |
| Drug Application Number | NDA210660 |
| Structured Product Labeling (SPL ID) | 3f3dc2d1-9383-4c95-b97a-3e25c588d8a4 |
| Structured Product Labeling (SPL Set ID) | e7652275-1c53-490c-82ad-e63867df5788 |
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