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Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0....

FDA Recall #D-0399-2022 — Class II — December 6, 2021

Recall #D-0399-2022 Date: December 6, 2021 Classification: Class II Status: Terminated

Product Description

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 For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Edge Pharma, LLC — Colchester, VT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

323 syringes

Distribution

nationwide

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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