Home / Recalls / AuroMedics Pharma LLC / D-0704-2018

D-0704-2018 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
46824 bags

Product Description

Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46.

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: CLF160002, CLF160004, CLF160005 exp May 2018; CLF160006, CLF160007 exp June 2018; CLF170027 exp July 2019; CLF170029 exp August 2019

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  • 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)
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  • 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)