FDAClass IIJanuary 6, 2021

Dexamethasone - Moxifloxacin PF Injection recall: Sterility Concern

Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ…

Why was Dexamethasone - Moxifloxacin PF Injection recalled?

Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 20JUN010, Exp 5/12/21

Product
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ…
Recalling firm
Imprimis NJOF, LLC
Quantity
6520 vials
Distribution
U.S.A. Nationwide
Recall date
January 6, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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