D-0515-2024 Class II Ongoing
FDA drug recall D-0515-2024 was initiated by Imprimis NJOF, LLC on May 14, 2024 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 18,980 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- June 5, 2024
- Initiation Date
- May 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,980 vials
Product Description
Moxifloxacin 0.8 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 71384-509-08
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 23OCT013, Exp. Date 10/10/2024