PlainRecalls
FDA Drug Moderate Class II Ongoing

Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08

Reported: May 8, 2024 Initiated: April 10, 2024 #D-0476-2024

Product Description

Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08

Reason for Recall

Subpotent Drug

Details

Recalling Firm
Imprimis NJOF, LLC
Units Affected
3320 bottles
Distribution
U.S. Nationwide
Location
Ledgewood, NJ

Frequently Asked Questions

What product was recalled?
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08. Recalled by Imprimis NJOF, LLC. Units affected: 3320 bottles.
Why was this product recalled?
Subpotent Drug
Which agency issued this recall?
This recall was issued by the FDA Drug on May 8, 2024. Severity: Moderate. Recall number: D-0476-2024.