PlainRecalls
FDA Drug Moderate Class II Ongoing

Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05

Reported: June 19, 2024 Initiated: May 14, 2024 #D-0548-2024

Product Description

Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Imprimis NJOF, LLC
Units Affected
4,280 boxes
Distribution
US Nationwide
Location
Ledgewood, NJ

Frequently Asked Questions

What product was recalled?
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05. Recalled by Imprimis NJOF, LLC. Units affected: 4,280 boxes.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on June 19, 2024. Severity: Moderate. Recall number: D-0548-2024.