FDAClass IIJune 5, 2024

Dexamethasone-Moxifloxacin- Ketorolac recall: Sterility Concern

Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only…

Why was Dexamethasone-Moxifloxacin- Ketorolac recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 #: 23MAY008, Exp. Date 5/1/24; 23OCT011, Exp. Date 10/26/24; 23NOV035, Exp. Date 12/6/24; 24JAN024, Exp. Date 1/14/25

Product
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only…
Recalling firm
Imprimis NJOF, LLC
Quantity
38,060 vials
Distribution
Nationwide within the United States
Recall date
June 5, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls