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.
Reported: May 9, 2018 Initiated: March 27, 2018 #D-0705-2018
Product Description
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 for Recall
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 261250 bags
- Distribution
- US Nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by AuroMedics Pharma LLC. Units affected: 261250 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 9, 2018. Severity: Moderate. Recall number: D-0705-2018.
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