Status
Terminated
Drug Enforcement D-1094-2023
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Classification
Class III
Report Date
August 30, 2023
Termination Date
January 22, 2024
Product Information
- 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.
- Product quantity
- 2,683 bottles
- Reason for recall
- Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
- Recall initiation reason
- —
- Initial firm notification
- N/A
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- Imprimis NJOF, LLC
- Address
-
1705 Route 46 Ste 6B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1094-2023
- Event ID
- 92848
- Recall initiation date
- August 10, 2023
- Center classification date
- August 21, 2023
- Code info
- Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.
- More code info
- —