CLASS III ONGOING Drug recall · Reported 8 May 2024 · FDA Enforcement Report
Epinephrine-Lidocaine HCl 0.25 mg/mL recalled by Imprimis NJOF
Imprimis Njof is recalling Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free Single-Use vials, distributed nationwide in the US. The recall was initiated on 10 Apr 2024 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-0478-2024
- FDA event ID
- 94372
- Recalling firm
- Imprimis Njof, Ledgewood, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 10 Apr 2024
- FDA classified
- 30 Apr 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 10 Apr 2024 | Recall initiated by company | |
| 30 Apr 2024 | Classified by FDA | +20 days |
| 8 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of specification for assay
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
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Out of specification for assay
Which lots are affected?
Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024
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 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 |
Other Epinephrine-lidocaine recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, mL Vials recalled | Imprimis Njof | Potency & Assay | Nationwide |
| Drug | CLASS II | Epinephrine-Lidocaine HCl 0.25 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS II | Epinephrine-Lidocaine HCl 0.25 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS III | Epinephrine-Lidocaine HCl (0.25mg/mL recalled by Imprimis NJOF | Imprimis Njof | Potency & Assay | Nationwide |