CLASS II Drug recall · Reported 9 May 2018 · FDA Enforcement Report
Levetiracetam in 54% Sodium Chloride Injection recalled
AuroMedics Pharma is recalling Levetiracetam in 54% Sodium Chloride Injection, 1,500 mg per (15 mg/mL), For Intravenous, distributed nationwide in the US. The recall was initiated on 27 Mar 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0707-2018
- FDA event ID
- 79772
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Brand
- Levetiracetam
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Mar 2018
- FDA classified
- 3 May 2018
- Reported
- 9 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Mar 2018 | Recall initiated by company | |
| 3 May 2018 | Classified by FDA | +37 days |
| 9 May 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Product as listed by the FDA
Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.
Where it was distributed
US Nationwide
Questions about this recall
Is Levetiracetam in 54% Sodium Chloride Injection, 1,500 mg per (15 mg/mL), For Intravenous recalled?
Yes. AuroMedics Pharma recalled Levetiracetam in 54% Sodium Chloride Injection, 1,500 mg per (15 mg/mL), For Intravenous on 27 Mar 2018. The recall is Class II and its status is Terminated. Recall number D-0707-2018.
Why was it recalled?
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Which lots are affected?
Lot/Batch #'s: CLV160004, CLV160005, and CLV160006 exp September 2018; CLV170011, CLV170015, CLV170016 exp June 2019
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Levetiracetam In Sodium Chloride recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levetiracetam in 75% Sodium Chloride Injection, 1000 mg recalledLevetiracetam | AuroMedics Pharma | Mold | Nationwide |
| Drug | CLASS II | Levetiracetam in 82% Sodium Chloride Injection, 500 mg recalledLevetiracetam | AuroMedics Pharma | Mold | Nationwide |