Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1% recall
FDA recall D-0476-2024 · initiated Apr 10, 2024
Imprimis NJOF, LLC recalled Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution… in Apr 2024 — an FDA Class II recall (D-0476-2024) because Subpotent Drug.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3320 bottles
Details
- 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
- Recalling company
- Imprimis NJOF, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Apr 10, 2024
- FDA report date
- May 8, 2024
Frequently asked
- Was Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution… recalled?
- Imprimis NJOF, LLC recalled Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution… in Apr 2024 — an FDA Class II recall (D-0476-2024) because Subpotent Drug. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution… recalled?
- Per the FDA enforcement record, the reason for recall D-0476-2024 was: Subpotent Drug
- Is a recalled Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution… are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot #: 23JUN031; Exp. 07/03/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0476-2024.