Recalling firm
Imprimis NJOF, LLC
Product type
Drug
Status
Completed
Report date
2025-07-30
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
2,890 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Sub-Potent Drug: Subpotent assay results during stability testing.
Product description
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.
Code / lot info
Lot: 25MAR032, Exp. 07/16/2025.
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.