Drug Enforcement D-0548-2024

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

June 19, 2024

Termination Date

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Product Information

Product description
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
Product quantity
4,280 boxes
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
US Nationwide

Location & Firm

Recalling firm
Imprimis NJOF, LLC
Address
1705 Route 46 Ste 6B, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0548-2024
Event ID
94552
Recall initiation date
May 14, 2024
Center classification date
June 7, 2024
Code info
Lot: 23NOV018 Exp. 6/17/24
More code info
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