CLASS III Drug recall · Reported 25 Oct 2023 · FDA Enforcement Report
Mydriatic-4: Tropicamide - Proparacaine - Phenylephrine recalled
Imprimis Njof is recalling Mydriatic-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic, distributed nationwide in the US. The recall was initiated on 20 Sep 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-0043-2024
- FDA event ID
- 93093
- Recalling firm
- Imprimis Njof, Ledgewood, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Sep 2023
- FDA classified
- 13 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 20 Sep 2023 | Recall initiated by company | |
| 13 Oct 2023 | Classified by FDA | +23 days |
| 25 Oct 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
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
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
Where it was distributed
Product was distributed to physician's offices nationwide.
Questions about this recall
Why was it recalled?
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Which lots are affected?
Lot#s: 22DEC065 (MDU), exp: 09/29/2023; 23JAN024 (MDU), exp: 10/13/2023; 23FEB024 (SDU), exp: 11/09/2023; 23MAR013 (SDU), exp: 12/01/2023; 23MAR033 (SDU), exp: 12/16/2023; 23MAY044 (SDU), exp: 03/23/2024;
Where was it sold?
Product was distributed to physician's offices nationwide.
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 |