Recalls / Class III
Class IIID-0040-2024
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
- Affected lot / code info
- 23APR018
Why it was recalled
Subpotent: Failing Test Results for Epinephrine
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
- 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-10-03
- FDA classified
- 2023-10-05
- Posted by FDA
- 2023-10-11
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0040-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.