FDA Recalls Eye Suspension Medication for Lack of Sterility Assurance
Imprimis NJOF, LLC is recalling one lot of a compounded ophthalmic suspension due to failure of sterility assurance. The product may be contaminated and pose a risk of serious eye infection.
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 with no reported illnesses or injuries. However, it qualifies as a risk-of-harm product where injury has not yet been reported: lack of sterility assurance in a compounded ophthalmic medication poses inherent risk of serious eye infections.
Plain-English summary
Imprimis NJOF, LLC is recalling Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension due to failure of sterility assurance. The affected lot is 23NOV018, which expires June 17, 2024. A total of 4,280 boxes were distributed nationwide.
The company determined that the product lacks adequate assurance of sterility. This means the medication may have become contaminated during manufacturing, which could cause serious eye infections in patients using the product.
The product is a prescription-only medication compounded by Imprimis NJOF, LLC, located in Ledgewood, New Jersey. It was distributed to healthcare providers and patients nationwide.
Patients and healthcare providers who have received this lot should not use it and should consult with an eye care provider or physician about alternative treatment options.
The recalled product
- Product
- Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
- Manufacturer
- Imprimis NJOF, LLC
- Affected units
- 4,280
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 (1)
- Lot: 23NOV018 Exp. 6/17/24
Distribution
Distributed nationwide across the United States.
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