CLASS III Drug recall · Reported 30 Aug 2023 · FDA Enforcement Report
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution recalled
Imprimis Njof is recalling Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, Imprimis NJOF, LLC, distributed nationwide in the US. The recall was initiated on 10 Aug 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1094-2023
- FDA event ID
- 92848
- Recalling firm
- Imprimis Njof, Ledgewood, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Aug 2023
- FDA classified
- 21 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 10 Aug 2023 | Recall initiated by company | |
| 21 Aug 2023 | Classified by FDA | +11 days |
| 30 Aug 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Which lots are affected?
Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Imprimis Njof
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Moxifloxacin, 1 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS II | Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL recalled | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS II | Tri-Moxi+¿ (Triamcinolone 9mg recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS III | Klarity-C Drops (Cyclosporine) recalled by Imprimis NJOF | Imprimis Njof | Potency & Assay | Nationwide |
| Drug | CLASS II | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, mL Vials recalled | Imprimis Njof | Potency & Assay | Nationwide |