← FDA ENFORCEMENT
D-1094-2023Class III

Imprimis NJOF, LLC

Recalling firm
Imprimis NJOF, LLC
Product type
Drug
Status
Terminated
Report date
2023-08-30
Distribution
Nationwide in the US
Firm state
NJ
Product quantity
2,683 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

Product description

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.

Code / lot info

Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.