Imprimis NJOF, LLC: Drug Recall

Recall #D-0043-2024 · 09/20/2023

Class III: Low Risk

Recall Details

Recall Number
D-0043-2024
Classification
Class III
Product Type
Drug
Recalling Firm
Imprimis NJOF, LLC
Status
Terminated
Date Initiated
09/20/2023
Location
Ledgewood, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,228 bags + 15,360 boxes

Reason for Recall

Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.

Product Description

MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05

Distribution Pattern

Product was distributed to physician's offices nationwide.

Other Recalls by Imprimis NJOF, LLC

View all recalls by Imprimis NJOF, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.