Drug 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.
D-1094-2023
Product summary
- Event
- Event 92848
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,683 bottles
- Official record key
drug-enforcement:D-1094-2023
Official wording
Reason: Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Code information: Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Subpotent