Compounded quadruple ophthalmic solution returned subpotent assay results in stability testing
A compounded Tropicamide-Proparacaine-Phenylephrine-Ketorolac sterile ophthalmic solution is being recalled because of subpotent assay results during stability testing. 2,890 vials are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall for an out-of-specification potency result, which the rubric places in the low band, with no health consequence stated.
Plain-English summary
Tropicamide-Proparacaine-Phenylephrine-Ketorolac Sterile Ophthalmic Solution, 1% / 0.5% / 2.5% / 0.5%, 5 mL, two 5 mL vials per carton, prescription only, from Imprimis NJOF, LLC of Ledgewood, New Jersey, NDC 71384-733-05, is being recalled. The action covers 2,890 vials.
The stated reason is a sub-potent drug: subpotent assay results during stability testing. The FDA classified the action as Class III, its least serious classification.
The affected lot is 25MAR032, expiring 07/16/2025. Distribution was nationwide in the USA. The vials are supplied to eye care facilities rather than sold to consumers.
Facilities should identify affected stock using the NDC and lot number above and follow the instructions issued by the compounder.
The recalled product
- Product
- Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
- Manufacturer
- Imprimis NJOF, LLC
- Hazard
- subpotent
- assay-failure
- stability-testing
- compounded-drug
- class-iii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 25MAR032
- Exp. 07/16/2025.
Distribution
Distributed nationwide across the United States.
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