Recalls / Class III
Class IIID-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.
- Affected lot / code info
- Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.
Why it was recalled
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Recalling firm
- Firm
- Imprimis NJOF, LLC
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 1705 Route 46 Ste 6B, N/A, Ledgewood, New Jersey 07852-9720
Distribution
- Quantity
- 2,683 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2023-08-10
- FDA classified
- 2023-08-21
- Posted by FDA
- 2023-08-30
- Terminated
- 2024-01-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1094-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.