Levetiracetam in 0.82% Sodium Chloride Injection recall: Sterility Concern
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.
Why was Levetiracetam in 0.82% Sodium Chloride Injection recalled?
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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.
- Recalling firm
- AuroMedics Pharma LLC
- Quantity
- 261250 bags
- Distribution
- US Nationwide
- Recall date
- May 9, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)