FDA recall D-1094-2023

Product

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.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2023-08-10

Report date

2023-08-30

Termination date

2024-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ledgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1094-2023