FDAClass IIApril 5, 2017

Ciprofloxacin in Dextrose recall: Sterility Concern

Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ…

Why was Ciprofloxacin in Dextrose recalled?

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

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 #: A051288, Exp. Sep 2017

Product
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ…
Recalling firm
Claris Lifesciences Inc
Quantity
18,360 units (765 cartons x 24 bags)
Distribution
Nationwide
Recall date
April 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls