FDAClass IIOctober 19, 2016

Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution recall: Sterility Concern

Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's…

Why was Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution recalled?

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

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?

All unexpired lots; Expirations dates of 09/21/2016 to 2/2/2017

Product
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's…
Recalling firm
Leiter's Compounding
Quantity
76,315 total units, all products
Distribution
Nationwide
Recall date
October 19, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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