Recalls / Class II
Class IID-0514-2024
Product
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
- Affected lot / code info
- Lot #: 23MAY008, Exp. Date 5/1/24; 23OCT011, Exp. Date 10/26/24; 23NOV035, Exp. Date 12/6/24; 24JAN024, Exp. Date 1/14/25
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Imprimis NJOF, LLC
- Type
- Voluntary: Firm initiated
- Address
- 1705 Route 46 Ste 6B, Ledgewood, New Jersey 07852-9720
Distribution
- Quantity
- 38,060 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-05-14
- FDA classified
- 2024-05-29
- Posted by FDA
- 2024-06-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0514-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.