FDA recall D-0305-2025

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.

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

Key facts

Status

Ongoing

Initiation date

2025-02-24

Report date

2025-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ledgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0305-2025