D-0305-2025 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 9, 2025
- Initiation Date
- February 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2822 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
FL and NY
Code Information
Lot 24OCT041, Exp 04/26/2025