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
Reported: October 25, 2023 Initiated: September 20, 2023 #D-0043-2024
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
Reason for Recall
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Details
- Recalling Firm
- Imprimis NJOF, LLC
- Units Affected
- 6,228 bags + 15,360 boxes
- Distribution
- Product was distributed to physician's offices nationwide.
- Location
- Ledgewood, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Imprimis NJOF, LLC. Units affected: 6,228 bags + 15,360 boxes.
Why was this product recalled? ▼
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 25, 2023. Severity: Low. Recall number: D-0043-2024.
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