Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01
Reported: June 5, 2024 Initiated: May 14, 2024 #D-0514-2024
Product Description
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Imprimis NJOF, LLC
- Units Affected
- 38,060 vials
- Distribution
- Nationwide within the United States
- Location
- Ledgewood, NJ
Frequently Asked Questions
What product was recalled? ▼
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01. Recalled by Imprimis NJOF, LLC. Units affected: 38,060 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-0514-2024.
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