D-0548-2024 Class II Ongoing
FDA drug recall D-0548-2024 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: 4,280 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2024
- Initiation Date
- May 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,280 boxes
Product Description
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
US Nationwide
Code Information
Lot: 23NOV018 Exp. 6/17/24