Moxifloxacin-Bromfenac Eye Drops Recalled for Subpotent Bromfenac Levels
Imprimis NJOF, LLC is recalling 2,683 bottles of Moxifloxacin-Bromfenac eye drops nationwide because Bromfenac levels fall below the 90-110% specification (affected lots: 22DEC047 exp. 9/16/23, 23FEB057 exp. 11/24/23).
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall of pharmaceutical product with subpotent active ingredient (Bromfenac below specification). No reported illnesses or injuries. Potency deficiency is a regulatory quality issue exceeding cosmetic concerns but without direct safety incidents.
Plain-English summary
Imprimis NJOF, LLC is recalling 2,683 bottles of Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 0.5%/0.075% (5mL bottle) due to subpotent Bromfenac levels. The affected medication was distributed nationwide. Recalled lot numbers are 22DEC047 (expiration 9/16/23) and 23FEB057 (expiration 11/24/23).
The Bromfenac component in the recalled product is present below the 90.0-110.0% specification range, meaning the medication does not meet established pharmaceutical quality standards.
Patients using this medication should contact their healthcare provider regarding this recall. Healthcare facilities and pharmacies should stop dispensing affected lots. For more information, contact Imprimis NJOF, LLC at 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, or (844)-446-6979.
The recalled product
- Product
- Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Ophthalmic Medication
- 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 #s: 22DEC047 exp 9/16/23
- 23FEB057 exp 11/24/23.
Distribution
Distributed nationwide across the United States.
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