FDAClass IIIAugust 30, 2023

Moxifloxacin - Bromfenac Sterile Ophthalmic Solution recall: Subpotent

Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852…

Why was Moxifloxacin - Bromfenac Sterile Ophthalmic Solution recalled?

Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

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 #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.

Product
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852…
Recalling firm
Imprimis NJOF, LLC
Quantity
2,683 bottles
Distribution
Nationwide in the US
Recall date
August 30, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls