Agency classClass IIOur severity:High FDA (Drugs)·D-0514-2024·Announced 2024-06-05

Intraocular injection drug recalled due to sterility assurance failure

Imprimis NJOF, LLC is recalling Dexamethasone-Moxifloxacin-Ketorolac intraocular injections (38,060 vials) due to lack of assurance of sterility. The affected lots 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 an FDA Class II recall of a risk-of-harm product (intraocular injection) where sterility assurance is lacking. No illnesses or injuries have been reported in the source material, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Imprimis NJOF, LLC is recalling Dexamethasone-Moxifloxacin-Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection. This recall affects 38,060 vials of a combination drug product intended for injection directly into the eye.

The affected lots are: 23MAY008 (expiration 5/1/24), 23OCT011 (expiration 10/26/24), 23NOV035 (expiration 12/6/24), and 24JAN024 (expiration 1/14/25). The product was distributed nationwide within the United States.

The recall is being issued because the manufacturer cannot assure the sterility of these batches. Sterility is a critical requirement for intraocular injectable products.

The recalled product

Product: Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/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 71384-513-01
Manufacturer: Imprimis NJOF, LLC
Category: Drug — Intraocular Injection
Hazard: lack-of-sterility
Affected units: 38,060

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 #: 23MAY008
Exp. Date 5/1/24
23OCT011
Exp. Date 10/26/24
23NOV035
Exp. Date 12/6/24
24JAN024
Exp. Date 1/14/25

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 →

Same manufacturer · Imprimis NJOF, LLC

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