D-0478-2024 Class III Ongoing
FDA drug recall D-0478-2024 was initiated by Imprimis NJOF, LLC on April 10, 2024 and is designated Class III. Reason for recall: Out of specification for assay The recall status is ongoing. Affected quantity: 15,414 units.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2024
- Initiation Date
- April 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,414 units
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
Reason for Recall
Out of specification for assay
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024