FDA Drug recall D-0707-2018
Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics…
- FDA Drug
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics… by Auromedics Pharma, citing lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0707-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-27 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | US |
Product
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.
Reason
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Identifiers
| ndc | 55150-246-47 |
|---|---|
| ndc | 55150-247-47 |
| ndc | 55150-248-47 |
| code_info | Lot/Batch #'s: CLV160004, CLV160005, and CLV160006 exp September 2018; CLV170011, CLV170015, CLV170016 exp June 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0707-2018%22
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