Reported Aug 30, 2023 · Terminated
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West,…
Imprimis NJOF, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Imprimis NJOF, LLC · 1705 Route 46 Ste 6B · Ledgewood, NJ · 07852-9720
Is this the product you have?
- 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
- NDC71384-311-05
- Lot codes and dates
Lot #s: 22DEC047 exp 9/16/2323FEB057 exp 11/24/23
- Amount recalled
- 2,683 bottles
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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