FDA-Drug2023-08-30Class III

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.

Imprimis NJOF, LLC
Hazard

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

Sold states
Nationwide in the US
Affected count
2,683 bottles
Manufactured in
1705 Route 46 Ste 6B, N/A, Ledgewood, NJ, United States
Products
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.

Official notice

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

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