PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: January 19, 2022 Initiated: December 3, 2021 #D-0368-2022

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

Details

Recalling Firm
Akorn, Inc.
Units Affected
8184 bottles
Distribution
Nationwide USA
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Akorn, Inc.. Units affected: 8184 bottles.
Why was this product recalled?
Labeling: Missing Label
Which agency issued this recall?
This recall was issued by the FDA Drug on January 19, 2022. Severity: Low. Recall number: D-0368-2022.