Drug product
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979
D-0040-2024
Product summary
- Event
- Event 93160
- Status
- Terminated
- Classification
- Class III
- Quantity
- 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)
- Official record key
drug-enforcement:D-0040-2024
Official wording
Reason: Subpotent: Failing Test Results for Epinephrine
Code information: 23APR018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent