Drug 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
D-0535-2025
Product summary
- Event
- Event 97183
- Status
- Completed
- Classification
- Class II
- Quantity
- 6,880 vials
- Official record key
drug-enforcement:D-0535-2025
Official wording
Reason: Sub-Potent Drug: Subpotent assay results during stability testing.
Code information: Lot: 24DEC017, Exp. 07/12/2025.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent