Home / Recalls / AuroMedics Pharma LLC / D-0574-2018

D-0574-2018 Class I Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
March 7, 2018
Initiation Date
January 12, 2018
Termination Date
April 1, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,072 bags

Product Description

Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46

Reason for Recall

Presence of Particulate Matter; contains visible particulate matter identified as mold.

Distribution Pattern

Nationwide

Code Information

Lot CLF160003, exp May 2018

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  • 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)
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