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Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMAC...

FDA Recall #D-0839-2020 — Class II — December 16, 2019

Recall #D-0839-2020 Date: December 16, 2019 Classification: Class II Status: Terminated

Product Description

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.

Reason for Recall

Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.

Recalling Firm

Akorn Inc — Lake Forest, IL

Classification

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

Product Type

Drugs

Product Quantity

16,078 bottles

Distribution

Nationwide in the USA and Puerto Rico

Code Information

Lot #: 364667, Exp 12/20/2019

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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