FDAClass IMarch 7, 2018

Levofloxacin in 5% Dextrose Injection recall: Particulate Matter

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…

Why was Levofloxacin in 5% Dextrose Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot CLF160003, exp May 2018

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…
Recalling firm
AuroMedics Pharma LLC
Quantity
6,072 bags
Distribution
Nationwide
Recall date
March 7, 2018
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls