Why it was recalled
Subpotent: Failing Test Results for Epinephrine
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
Lot numbers, UPCs & expiration codes
23APR018
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0040-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 3, 2023
- FDA report date
- Oct 11, 2023
- Quantity
- 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-0040-2024, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93160
- Address
- 1705 Route 46 Ste 6B
- Code information
- 23APR018
- Postal code
- 07852-9720
- Report date
- Oct 11, 2023
- Product type
- Drugs
- Recall number
- D-0040-2024
- Classification
- Class III
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)
- Termination date
- Mar 21, 2025
- Reason for recall
- Subpotent: Failing Test Results for Epinephrine
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 3, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2023