Drug product
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
D-0305-2025
Product summary
- Event
- Event 96329
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2822 bottles
- Official record key
drug-enforcement:D-0305-2025
Official wording
Reason: Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Code information: Lot 24OCT041, Exp 04/26/2025
Distribution pattern: FL and NY
Derived failure modes
-
Potency or specification failure
subpotent