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Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manuf...

FDA Recall #D-0368-2022 — Class III — December 3, 2021

Recall #D-0368-2022 Date: December 3, 2021 Classification: Class III Status: Terminated

Product Description

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34

Reason for Recall

Labeling: Missing Label

Recalling Firm

Akorn, Inc. — Lake Forest, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

8184 bottles

Distribution

Nationwide USA

Code Information

Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023

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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