Recalls / Class II
Class IID-0548-2024
Product
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
- Affected lot / code info
- Lot: 23NOV018 Exp. 6/17/24
Why it was recalled
Lack of Assurance of Sterility
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
- 4,280 boxes
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2024-05-14
- FDA classified
- 2024-06-07
- Posted by FDA
- 2024-06-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0548-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.