FDA Recall D-0478-2024
Imprimis NJOF, LLC · Ledgewood, NJ
Class III Ongoing 764 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
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
Recall record
- Recall number
D-0478-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2024-04-10
- Classified by FDA Center
- 2024-04-30
- FDA published
- 2024-05-08
- Recalling firm
- Imprimis NJOF, LLC
- Firm location
- Ledgewood, NJ
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.