FDA Drugs recall ·
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL… recall
- Recall number
- D-0535-2025
- Date
- (initiated July 9, 2025)
- Company / brand
- Imprimis NJOF, LLC
1705 Route 46 Ste 6B, Ledgewood, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 6,880 vials
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
Why was it recalled?
Sub-Potent Drug: Subpotent assay results during stability testing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 24DEC017, Exp. 07/12/2025.
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0535-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.