CLASS II ONGOING Drug recall · Reported 5 Jun 2024 · FDA Enforcement Report
Moxifloxacin 0.8 mg/ Preservative-Free Single-Use vials recalled
Imprimis Njof is recalling Moxifloxacin 0.8 mg/ Preservative-Free Single-Use vials for Intraocular Injection, distributed nationwide in the US. The recall was initiated on 14 May 2024 and the FDA has classified it as Class II.
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-0515-2024
- FDA event ID
- 94551
- Recalling firm
- Imprimis Njof, Ledgewood, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 May 2024
- FDA classified
- 29 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 14 May 2024 | Recall initiated by company | |
| 29 May 2024 | Classified by FDA | +15 days |
| 5 Jun 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 23OCT013, Exp. Date 10/10/2024
Where was it sold?
Nationwide within the United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
4 other products · FDA event 94551This product is part of a recall event; the main page for the event is Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL recalled | Imprimis Njof | Sterility | Nationwide | |
| CLASS II | Moxifloxacin 4 mg/ Preservative-Free Single-Use vials recalled | Imprimis Njof | Sterility | Nationwide | |
| CLASS II | Dexamethasone-Moxifloxacin (1 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Sterility | Nationwide | |
| CLASS II | Epinephrine-Lidocaine HCl 0.25 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Sterility | Nationwide |
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 |
Other Moxifloxacin recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Moxifloxacin 4 mg/ Preservative-Free Single-Use vials recalled | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin 5mg/ml in a Single- Dose Vial recalled by Denver Solutions | Denver Solutions | Particulate Matter | Nationwide |
| Drug | CLASS II | Moxifloxacin in Balanced Salt Solution, Solution recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin in Balanced Salt Solution 400 mcg/ (100 mcg/ syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin HCl Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |