Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJO...
FDA Recall #D-0177-2021 — Class II — December 17, 2020
Product Description
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979
Reason for Recall
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Recalling Firm
Imprimis NJOF, LLC — Ledgewood, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6520 vials
Distribution
U.S.A. Nationwide
Code Information
Lot#: 20JUN010, Exp 5/12/21
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated