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Recall Observatory FDA recall evidence

Drug product

Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01

D-0513-2024

May 14, 2024

Class II

Product summary

Firm
Imprimis NJOF, LLC
Event
Event 94551
Status
Ongoing
Classification
Class II
Quantity
39,700 vials
Official record key
drug-enforcement:D-0513-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 23MAY016, Exp. Date 5/8/24; 23JUL016, Exp. Date 7/10/24; 23AUG034, Exp. Date 8/16/24; 23DEC014, Exp. Date 12/10/24

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility