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.
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: 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
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.
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