Class II · Moderate risk
N-Acetyl-L-Cysteine for Injection
Lack of Assurance of Sterility
ELCYS (cysteine hydrochloride injection)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Silicone
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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).
Affected NDCs
51754-1007-01
51754-1007-03
Compare with the code on your package — it is the most precise check available.
Drug: Cysteine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Elcys Cysteine Hydrochloride NDC 51754-1007 |
10 mg/mL | Injection, Solution Intravenous |
Exela Pharma Sciences, LLC | Rx |
- Recalling firm
- Exela Pharma Sciences LLC
- NDC code
- 51754-1007-1
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0118-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
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Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Class II · Moderate risk
N-A-C
Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
Class II · Moderate risk
5% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Class II · Moderate risk
10% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Other recalls by Exela Pharma Sciences LLC
All 2023 recalls
Class II · Moderate risk
4.2% Sodium Bicarbonate Injection
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
Class I · High risk
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Presence of Particulate Matter: Silicone
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter: Silicone
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