Moxifloxacin Intraocular Injection Recalled for Sterility Assurance
Imprimis NJOF, LLC is recalling specific lots of Moxifloxacin intraocular injections nationwide due to lack of assurance of sterility.
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 drug recall for a risk-of-harm product where no illnesses or injuries have been reported. The lack of sterility assurance is a serious risk for intraocular injection use, justifying a High severity rating.
Plain-English summary
Imprimis NJOF, LLC is recalling Moxifloxacin 4 mg/0.8 mL Preservative-Free Single-Use vials for intraocular injection. A total of 165,920 vials are affected, distributed nationwide within the United States.
The recall is issued because the affected lots lack assurance of sterility. For intraocular injections, sterility is critical to prevent serious eye infections.
The affected lot numbers include 23JUN003, 23JUL035, 23AUG033, 23AUG043, 23SEP001, 23OCT002, 23OCT031, 23NOV011, and 24FEB027, with expiration dates ranging from May 2024 through February 2025. Patients and healthcare providers should discontinue use of these lots and contact their healthcare provider or the manufacturer for further guidance.
The recalled product
- Product
- Moxifloxacin 4 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 71384-511-08
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Ophthalmic Injection
- Hazard
- Affected units
- 165,920
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 (18)
- Lot #: 23JUN003
- Exp. Date 5/29/2024
- 23JUL035
- Exp. Date 7/24/2024
- 23AUG033
- Exp. Date 8/14/2024
- 23AUG043
- Exp. Date 8/21/2024
- 23SEP001
- Exp. Date 9/26/2024
- 23OCT002
- Exp. Date 10/4/2024
- 23OCT031
- Exp. Date 10/31/2024
- 23NOV011
- Exp. Date 11/28/2024
- 24FEB027
- Exp. Date 2/15/2025
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.
See all 5 products in this recall →Related recalls
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