Status
Terminated
Drug Enforcement D-0043-2024
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Classification
Class III
Report Date
October 25, 2023
Termination Date
July 17, 2025
Product Information
- Product description
- MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
- Product quantity
- 6,228 bags + 15,360 boxes
- Reason for recall
- Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to physician's offices nationwide.
Location & Firm
- Recalling firm
- Imprimis NJOF, LLC
- Address
-
1705 Route 46 Ste 6B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0043-2024
- Event ID
- 93093
- Recall initiation date
- September 20, 2023
- Center classification date
- October 13, 2023
- Code info
- Lot#s: 22DEC065 (MDU), exp: 09/29/2023; 23JAN024 (MDU), exp: 10/13/2023; 23FEB024 (SDU), exp: 11/09/2023; 23MAR013 (SDU), exp: 12/01/2023; 23MAR033 (SDU), exp: 12/16/2023; 23MAY044 (SDU), exp: 03/23/2024;
- More code info
- —