Recalls / Class II
Class IID-0535-2025
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
- Affected lot / code info
- Lot: 24DEC017, Exp. 07/12/2025.
Why it was recalled
Sub-Potent Drug: Subpotent assay results during stability testing.
Recalling firm
- Firm
- Imprimis NJOF, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1705 Route 46 Ste 6B, N/A, Ledgewood, New Jersey 07852-9720
Distribution
- Quantity
- 6,880 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-07-09
- FDA classified
- 2025-07-21
- Posted by FDA
- 2025-07-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0535-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.