Status
Ongoing
Drug Enforcement D-0514-2024
Lack of Assurance of Sterility
Classification
Class II
Report Date
June 5, 2024
Termination Date
—
Product Information
- 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
- Product quantity
- 38,060 vials
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Imprimis NJOF, LLC
- Address
-
1705 Route 46 Ste 6B
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0514-2024
- Event ID
- 94551
- Recall initiation date
- May 14, 2024
- Center classification date
- May 29, 2024
- 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
- More code info
- —