MYDRIATIC-4: Tropicamide — Class III drug recall D-0043-2024
Terminated recall by Imprimis NJOF, LLC, reported 2023-10-25, distributed nationwide. Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label cla
| Recall number | D-0043-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Imprimis NJOF, LLC, Ledgewood, NJ, United States |
| Recall initiated | 2023-09-20 |
| Classified | 2023-10-13 |
| Reported by FDA | 2023-10-25 |
| Terminated | 2025-07-17 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency, specification failure |
| NDC | 71384-0632-05 |
| Lot numbers | 22DEC065 |
| Expiration dates | 2023-09-29, 2023-10-13, 2023-11-09, 2023-12-01, 2023-12-16, 2024-03-23 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0043-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.