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.

FDA recall notice · announced August 30, 2023 · Imprimis Njof

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the US
Lot/code information: Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.
Quantity: 2,683 bottles
Status: Terminated
Products in this recall event:
- 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. (D-1094-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.