PlainRecalls
FDA Drug Low Class III Terminated

Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.

Reported: August 30, 2023 Initiated: August 10, 2023 #D-1094-2023

Product Description

Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.

Reason for Recall

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

Details

Recalling Firm
Imprimis NJOF, LLC
Units Affected
2,683 bottles
Distribution
Nationwide in the US
Location
Ledgewood, NJ

Frequently Asked Questions

What product was recalled?
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.. Recalled by Imprimis NJOF, LLC. Units affected: 2,683 bottles.
Why was this product recalled?
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 30, 2023. Severity: Low. Recall number: D-1094-2023.