Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
Reported: April 9, 2025 Initiated: February 24, 2025 #D-0305-2025
Product Description
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
Reason for Recall
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Details
- Recalling Firm
- Imprimis NJOF, LLC
- Units Affected
- 2822 bottles
- Distribution
- FL and NY
- Location
- Ledgewood, NJ
Frequently Asked Questions
What product was recalled? ▼
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.. Recalled by Imprimis NJOF, LLC. Units affected: 2822 bottles.
Why was this product recalled? ▼
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 9, 2025. Severity: Low. Recall number: D-0305-2025.
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