Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Eugia Pharma Specialities Limited | Sangareddy, India | Makes it, tests it and packages it | Serious problems, FDA actionFeb 6, 2026 · 7 inspections, 2 with FDA action |
Recalls
- Mar 27, 2018 · Class II · AuroMedics Pharma LLC
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lots: Lot/Batch #'s: CLZ160001, CLZ160002, CLZ160003, CLZ160004 exp July 2018; CLZ160005, CLZ160006, CLZ160008, CLZ160009, CLZ160010 and CLZ160012, exp August 2018; CLZ160013, CLZ160014, CLZ160015, CLZ160016, exp October 2018; CLZ160017, CLZ160018, CLZ160019, CLZ160021, CLZ160022, CLZ16002… - Dec 20, 2017 · Class I · AuroMedics Pharma LLC
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Lots: Lot # CLZ160007, Exp August 2018
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Linezolid: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 600 mg per 300 mL
- Approval
- ANDA ANDA206917
- On the market since
- Aug 4, 2016
- Package NDCs
55150-242-51- Official label
- DailyMed (National Library of Medicine), updated Jul 13, 2026
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