WhichRecall
Class IIIReported 2025-07-30

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.

Recalled by Imprimis NJOF, LLC

Reason for Recall

Sub-Potent Drug: Subpotent assay results during stability testing.

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Recall Number
D-0536-2025
Classification
Class III
Status
Ongoing
Category
drug
Initiated
2025-07-09
Reported
2025-07-30
Distribution
Nationwide in the USA
Code Info
Lot: 25MAR032, Exp. 07/16/2025.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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