FDAClass IIFebruary 2, 2022

Dexamethasone sodium phosphate recall: Sterility Concern

Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe…

Why was Dexamethasone sodium phosphate recalled?

Lack of Assurance of Sterility

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?

09-2021-28@1 01/10/2022

Product
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe…
Recalling firm
Edge Pharma, LLC
Quantity
323 syringes
Distribution
nationwide
Recall date
February 2, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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