Drug product
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
D-0043-2024
Product summary
- Event
- Event 93093
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,228 bags + 15,360 boxes
- Official record key
drug-enforcement:D-0043-2024
Official wording
Reason: Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Code information: 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;
Distribution pattern: Product was distributed to physician's offices nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent