Home / Recalls / AuroMedics Pharma LLC / D-0706-2018

D-0706-2018 Class II Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
May 9, 2018
Initiation Date
March 27, 2018
Termination Date
February 18, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
188941 bags

Product Description

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.

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 Pattern

US Nationwide

Code Information

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

Other recalls by AuroMedics Pharma LLC

  • D-0020-2023 Class II — Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Sy (September 30, 2022)
  • D-0013-2023 Class II — Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx onl (September 26, 2022)
  • D-1551-2022 Class III — Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose v (September 26, 2022)
  • D-0556-2022 Class I — Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in (January 26, 2022)
  • D-0248-2021 Class II — Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, (December 30, 2020)
  • D-0852-2020 Class II — Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bott (February 7, 2020)
  • D-0853-2020 Class III — Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vi (February 7, 2020)
  • D-0789-2020 Class III — Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For To (December 2, 2019)
  • D-0574-2020 Class II — Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count (November 25, 2019)
  • D-0636-2020 Class I — Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Au (November 20, 2019)