Status
Terminated
Drug Enforcement D-0040-2024
Subpotent: Failing Test Results for Epinephrine
Classification
Class III
Report Date
October 11, 2023
Termination Date
March 21, 2025
Product Information
- Product description
- 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
- Product quantity
- 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)
- Reason for recall
- Subpotent: Failing Test Results for Epinephrine
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Imprimis NJOF, LLC
- Address
-
1705 Route 46 Ste 6B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0040-2024
- Event ID
- 93160
- Recall initiation date
- October 3, 2023
- Center classification date
- October 5, 2023
- Code info
- 23APR018
- More code info
- —