Intraocular Injection Recalled for Sterility Assurance Failure
Imprimis NJOF, LLC is recalling preservative-free intraocular injection vials of Dexamethasone-Moxifloxacin due to lack of assurance of sterility. Approximately 39,700 vials were distributed nationwide.
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 a sterility assurance failure on a high-risk intraocular injectable product where no illnesses or injuries have been reported. It meets the criterion for a risk-of-harm product where injury has not yet been reported, qualifying it as High severity.
Plain-English summary
Imprimis NJOF, LLC is recalling Dexamethasone-Moxifloxacin preservative-free intraocular injection vials in 1 mg/mL and 5 mg/mL concentrations. The product is supplied in 1 mL single-use vials intended for injection directly into the eye.
The recall was initiated due to lack of assurance of sterility. Approximately 39,700 vials have been distributed nationwide across the United States. The affected lots are: Lot #23MAY016 (expiration 5/8/24), Lot #23JUL016 (expiration 7/10/24), Lot #23AUG034 (expiration 8/16/24), and Lot #23DEC014 (expiration 12/10/24).
Healthcare providers and facilities that received these vials should discontinue use immediately. Patients who have received injections from these vials should contact their healthcare provider. No illnesses or injuries have been reported in association with this recall.
The recalled product
- Product
- Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Intraocular Injection
- Affected units
- 39,700
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 (8)
- Lot #: 23MAY016
- Exp. Date 5/8/24
- 23JUL016
- Exp. Date 7/10/24
- 23AUG034
- Exp. Date 8/16/24
- 23DEC014
- Exp. Date 12/10/24
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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