Reported Apr 9, 2025 · Ongoing
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15…
Imprimis NJOF, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Imprimis NJOF, LLC · 1705 Route 46 Ste 6B · Ledgewood, NJ · 07852-9720
Is this the product you have?
- 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
- NDC71384-733-05
- Lot codes and dates
Lot 24OCT041Exp 04/26/2025
- Amount recalled
- 2822 bottles
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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