NDC 55150-246

Levetiracetam 500 mg per 100 mL injection, solution

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

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: CLV160016, CLV160017, and CLV160018, exp Sept 2018, CLV160019, exp Oct 2018, CLV160020, CLV160021, and CLV160031, exp Nov 2018; CLV160032 and CLV170001, exp 12/18; CLV170008 and CLV170009, exp April 2019, CLV170020, CLV170021 and CLV170022, exp Oct 2019
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: CLV160013, CLV160014 and CLV160015, exp Sept 2018; CLV160022, CLV160023, CLV160024, CLV160025, CLV160026, CLV160027, CLV160028, CLV160029, CLV160030 exp Oct 2018; CLV170002, Dec 2018; CLV170010, exp April 2019; CLV170027, CLV170028, CLV170029 and CLV170030 exp Oct 2019
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: CLV160004, CLV160005, and CLV160006 exp September 2018; CLV170011, CLV170015, CLV170016 exp June 2019

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Levetiracetam: every company that makes it
Form: injection, solution, intravenous
Strength: 500 mg per 100 mL
Approval: ANDA ANDA207160
On the market since: Jan 4, 2017
Package NDCs: 55150-246-47
Official label: DailyMed (National Library of Medicine), updated Apr 1, 2024

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