Drug Enforcement D-0536-2025

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

Status

Ongoing

Classification

Class III

Report Date

July 30, 2025

Termination Date

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Product Information

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.
Product quantity
2,890 vials
Reason for recall
Sub-Potent Drug: Subpotent assay results during stability testing.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Imprimis NJOF, LLC
Address
1705 Route 46 Ste 6B, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0536-2025
Event ID
97183
Recall initiation date
July 9, 2025
Center classification date
July 21, 2025
Code info
Lot: 25MAR032, Exp. 07/16/2025.
More code info
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