Status
Ongoing
Drug Enforcement D-0513-2024
Lack of Assurance of Sterility
Classification
Class II
Report Date
June 5, 2024
Termination Date
—
Product Information
- Product description
- Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/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 71384-512-01
- Product quantity
- 39,700 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-0513-2024
- Event ID
- 94551
- Recall initiation date
- May 14, 2024
- Center classification date
- May 29, 2024
- Code info
- Lot #: 23MAY016, Exp. Date 5/8/24; 23JUL016, Exp. Date 7/10/24; 23AUG034, Exp. Date 8/16/24; 23DEC014, Exp. Date 12/10/24
- More code info
- —