Moxifloxacin intraocular injection vials recalled for sterility assurance failure
Imprimis NJOF, LLC recalls Moxifloxacin intraocular injection vials nationwide due to lack of sterility assurance. The 18,980 affected vials (lot 23OCT013) should not be used.
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: This is an FDA Class II recall of an injectable medication intended for intraocular use. While no illnesses or injuries are reported in the source, the lack of sterility assurance for a product injected directly into the eye poses a significant potential risk of serious infection, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Imprimis NJOF, LLC is recalling 18,980 vials of Moxifloxacin 0.8 mg/0.8 mL Preservative-Free single-use vials intended for intraocular injection. The manufacturer identified a lack of assurance of sterility in the product.
The affected vials were distributed nationwide and are identified by lot number 23OCT013 with an expiration date of 10/10/2024 (NDC 71384-509-08). Healthcare providers and patients should not use vials from this lot.
Patients or healthcare providers who may have vials from lot 23OCT013 should cease use and consult their healthcare provider for guidance.
The recalled product
- Product
- Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Intraocular Injection
- Hazard
- Affected units
- 18,980
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 #: 23OCT013
- Exp. Date 10/10/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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