FDA Issues Nationwide Recall of Subpotent Ophthalmic Eye Drops
The FDA is recalling 3,320 bottles of compounded ophthalmic solution due to subpotency. The affected product does not contain adequate amounts of active medication.
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: FDA Class II recall of a compounded drug containing subpotent active ingredients. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product where potential injury has not yet occurred, meeting the threshold for High severity.
Plain-English summary
The FDA has issued a recall of Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution compounded by Imprimis NJOF, LLC located in Ledgewood, New Jersey. The affected product is identified by NDC 71384-340-08, with Lot #23JUN031 and expiration date of July 3, 2024. Approximately 3,320 bottles of 8mL solution are subject to this recall.
The product was recalled due to subpotency, which means the compounded solution does not contain adequate levels of its active ingredients. Subpotent medication may result in reduced medication effectiveness.
The product was distributed nationwide in the United States. The recall remains ongoing and was initiated voluntarily by Imprimis NJOF, LLC on April 10, 2024.
The recalled product
- Product
- Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Ophthalmic
- Hazard
- subpotency
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 (2)
- Lot #: 23JUN031
- Exp. 07/03/2024
Distribution
Distributed nationwide across the United States.
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