Why it was recalled
Out of specification for assay
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024
Where it was sold
Nationwide within the United States
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-0478-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Apr 10, 2024
- FDA report date
- May 8, 2024
- Quantity
- 15,414 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-0478-2024, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94372
- Address
- 1705 Route 46 Ste 6B
- Code information
- Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024
- Postal code
- 07852-9720
- Report date
- May 8, 2024
- Product type
- Drugs
- Recall number
- D-0478-2024
- Classification
- Class III
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 15,414 units
- Reason for recall
- Out of specification for assay
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 10, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 30, 2024