Drug product
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
D-0478-2024
Product summary
- Event
- Event 94372
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 15,414 units
- Official record key
drug-enforcement:D-0478-2024
Official wording
Reason: Out of specification for assay
Code information: Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out of specification