FDA Drug recall D-0705-2018
Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Ph…
- FDA Drug
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Ph… 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-0705-2018 |
| 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 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47.
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: CLV160016, CLV160017, and CLV160018, exp Sept 2018, CLV160019, exp Oct 2018, CLV160020, CLV160021, and…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 |
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-0705-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.