Intraocular Eye Injection Recalled for Glass-Like Particulate Matter
Imprimis NJOF is recalling intraocular injections containing glass-like particles distributed nationwide. Patients who received this product should contact their healthcare provider.
What this means for you
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: FDA Class II recall involving glass-like particles in an intraocular injection used in eye surgery. The source does not report any illnesses or injuries to date; this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Imprimis NJOF, LLC is recalling Dexamethasone + Moxifloxacin 1 mg/mL and 5 mg/mL intraocular injections due to the presence of glass-like particulate matter.
The recall affects pre-filled syringes from lot 25MAY051 (expiring 06/26/2026) and lot 25AUG003 (expiring 08/07/2026). A total of 778 boxes containing 15,540 pre-filled syringes were distributed across the United States. Glass particles in an intraocular injection pose a potential risk of serious eye damage if introduced during eye surgery.
Healthcare providers and patients should contact Imprimis NJOF, LLC or consult their healthcare provider immediately if they have questions about whether they may have received an affected product.
The recalled product
- Product
- Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
- Manufacturer
- Imprimis NJOF, LLC
- Hazard
- glass-particles
- contamination
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 (4)
- Lot: 25MAY051
- Expires: 06/26/2026
- 25AUG003
- Expires:08/07/2026
Distribution
Distributed nationwide across the United States.
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