January 2018 FDA Recall Levofloxacin by Auromedics Pharma Llc
D-0574-2018 - Presence of Particulate Matter; contains visible particulate matter identified as mold.

This Class I drug recall was voluntarily initiated by Auromedics Pharma Llc on January 12, 2018 for the product Levofloxacin. The FDA reported the reason for recall as presence of particulate matter; contains visible particulate matter identified as mold.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0574-2018

Reason for Recall
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Initiated
01-12-2018
Reported
03-07-2018
Quantity
6,072 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78932
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AuroMedics Pharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-01-2020
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot CLF160003, exp May 2018

Affected Packages Involved in this Recall

55150-243-46 Levofloxacin
55150-244-47 Levofloxacin
55150-245-52 Levofloxacin