# FDA recall D-0043-2024

> **Imprimis NJOF, LLC** · Class III · drug recall initiated 2023-09-20.

## Product

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

## Reason for recall

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

## Distribution

Product was distributed to physician's offices nationwide.

## Key facts

- **Recall number:** D-0043-2024
- **Recalling firm:** Imprimis NJOF, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-09-20
- **Report date:** 2023-10-25
- **Termination date:** 2025-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ledgewood, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0043-2024

## Citation

> AI Analytics. FDA recall D-0043-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0043-2024. Source: US FDA. Licensed CC0.

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