Recalls / Class II
Class IID-0476-2024
Product
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08
- Affected lot / code info
- Lot #: 23JUN031; Exp. 07/03/2024
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Imprimis NJOF, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1705 Route 46 Ste 6B, Ledgewood, New Jersey 07852-9720
Distribution
- Quantity
- 3320 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2024-04-10
- FDA classified
- 2024-04-29
- Posted by FDA
- 2024-05-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0476-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.