Intraocular injection syringes recalled over glass-like particulate matter
Imprimis NJOF is recalling 596 boxes containing 11,920 pre-filled syringes of Dexamethasone, Moxifloxacin and Ketorolac intraocular injection over glass-like particles.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: glass-like particles in an intraocular injection are a stated contaminant, and no injuries are reported.
Plain-English summary
Dexamethasone, Moxifloxacin and Ketorolac (1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, from Imprimis NJOF, LLC of Ledgewood, New Jersey, under NDC 71384-513-01, is being recalled.
The reason given in the enforcement record is the presence of particulate matter, described as glass-like particles.
The recall covers 596 boxes of 11,920 pre-filled syringes from lots 25APR001A and 25APR001B, expiring 04/03/2026. Distribution was nationwide in the US. The FDA has classified the action as Class II.
Glass-like particles in a product injected into the eye are a stated physical contaminant. Facilities should quarantine affected lots and follow the firm's instructions.
The recalled product
- Product
- Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Intraocular injection
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 (3)
- Lot: 25APR001A
- 25APR001B
- Expires: 04/03/2026.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Imprimis NJOF, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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