Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Exela Pharma Sciences, LLC. | Lenoir, NC, United States | Makes it, packages it and labels it | Serious problems, FDA actionNov 15, 2024 · 12 inspections, 1 with FDA action |
Recalls
- Oct 18, 2023 · Class I · Exela Pharma Sciences LLC
Presence of Particulate Matter: Silicone
Lots: Lot # 10000798, Expiration Date 03/31/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cysteine: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 10 mg per 1 mL
- Approval
- NDA NDA210660
- On the market since
- May 28, 2019
- Package NDCs
51754-1007-151754-1007-3- Official label
- DailyMed (National Library of Medicine), updated Feb 1, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?