Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
Reported: June 5, 2024 Initiated: May 14, 2024 #D-0519-2024
Product Description
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Imprimis NJOF, LLC
- Units Affected
- 74,440 units
- Distribution
- Nationwide within the United States
- Location
- Ledgewood, NJ
Frequently Asked Questions
What product was recalled? ▼
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01. Recalled by Imprimis NJOF, LLC. Units affected: 74,440 units.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 5, 2024. Severity: Moderate. Recall number: D-0519-2024.
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