AuroMedics Pharma LLC: Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC

Is my product affected?

Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47.

• Brand LEVETIRACETAM

Check against the official notice below — it lists the full affected range.

What happened

AuroMedics Pharma LLC is recalling Levetiracetam in 0.75% Sodium Chloride Injection (1000 mg per 100 mL) distributed nationwide. The recall affects approximately 188,941 bags across multiple lot numbers with expiration dates ranging from September 2018 through October 2019. The product was recalled due to a lack of assurance of sterility after a customer reported leaking bags with mold found between the outer bag and overwrap.

The recall encompasses specific lot numbers: CLV160013, CLV160014, and CLV160015 (expiring September 2018); CLV160022, CLV160023, CLV160024, CLV160025, CLV160026, CLV160027, CLV160028, CLV160029, and CLV160030 (expiring October 2018); CLV170002 (expiring December 2018); CLV170010 (expiring April 2019); and CLV170027, CLV170028, CLV170029, and CLV170030 (expiring October 2019). The source document does not specify what action affected consumers or healthcare facilities should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Details from the source

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 Distribution: US Nationwide Quantity: 188941 bags Lot/code info: Lot/Batch #'s: CLV160013, CLV160014 and CLV160015, exp Sept 2018; CLV160022, CLV160023, CLV160024, CLV160025, CLV160026, CLV160027, CLV160028, CLV160029, CLV160030 exp Oct 2018; CLV170002, Dec 2018; CLV170010, exp April 2019; CLV170027, CLV170028, CLV170029 and CLV170030 exp Oct 2019

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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