Class III
Ongoing
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.
This recall is currently active, issued April 9, 2025. It was issued by Imprimis Njof, Llc.
- Company
- Imprimis Njof, Llc
- Recall Initiated
- February 24, 2025
- Posted
- April 9, 2025
- Recall Number
- D-0305-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2822 bottles
- Firm Location
- Ledgewood, NJ, United States
- Official Source
- View on FDA website ↗
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
FL and NY
Lot / Code Info
Lot 24OCT041, Exp 04/26/2025
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