Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
Reported: June 5, 2024 Initiated: May 14, 2024 #D-0516-2024
Product Description
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Imprimis NJOF, LLC
- Units Affected
- 165,920 vials
- Distribution
- Nationwide within the United States
- Location
- Ledgewood, NJ
Frequently Asked Questions
What product was recalled? ▼
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08. Recalled by Imprimis NJOF, LLC. Units affected: 165,920 vials.
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-0516-2024.
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