December 2017 FDA Recall Linezolid by Auromedics Pharma Llc
D-0337-2018 - Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

This Class I drug recall was voluntarily initiated by Auromedics Pharma Llc on December 20, 2017 for the product Linezolid. The FDA reported the reason for recall as presence of particulate matter; white particulate matter identified as mold was found in one bag. The product was distributed in Product was distributed throughout United States. and the recall is currently terminated.

Recall Number: D-0337-2018

Reason for Recall
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Initiated
12-20-2017
Reported
02-14-2018
Quantity
9,050 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78800
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-24-2019
Product Description About Product Description
Full technical description of the product.
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51

Batch or Lot Expiration Information

Lot# CLZ160007, Exp August 2018

Affected Packages Involved in this Recall

55150-242-51 Linezolid