Drugplain

Oxycodone Hydrochloride Oral Solution 100 mg/5mL

Oxycodone Hydrochloride Oral Solution · SOLUTION · Aurolife Pharma, LLC

5 Recalls on RecordCurrently in Shortage
Plain English

Oxycodone Hydrochloride Oral Solution is a solution containing oxycodone hydrochloride oral solution at 100 mg/5mL, taken oral. Manufactured by Aurolife Pharma, LLC.

Key Facts

Brand Name
Oxycodone Hydrochloride Oral Solution
Generic Name
Oxycodone Hydrochloride Oral Solution
NDC Code (Product)
13107-262
Manufacturer
Aurolife Pharma, LLC
Strength
100 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
ANDA212429
Marketing Start
01/27/2020

Recall History

5 Recalls on Record
Class III12/03/2021

Akorn, Inc.

Labeling: Missing Label

TerminatedVoluntary: Firm initiated
Class II04/18/2016

VistaPharm, Inc.

Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.

TerminatedVoluntary: Firm initiated
Class II02/22/2022

American Health Packaging

Impurity failure at 0-time of the repackaged lot.

TerminatedVoluntary: Firm initiated
Class II01/18/2017

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

TerminatedVoluntary: Firm initiated
Class III12/23/2020

Genus Lifesciences Inc.

Presence of Foreign Substance: Particulate matter was found in multiple lots of product.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Oxycodone Hydrochloride Oral Solution used for?

Oxycodone Hydrochloride Oral Solution contains Oxycodone Hydrochloride Oral Solution. It is a solution taken oral. Consult your doctor for specific uses.

Is Oxycodone Hydrochloride Oral Solution a controlled substance?

Yes, Oxycodone Hydrochloride Oral Solution is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Oxycodone Hydrochloride Oral Solution?

The generic name for Oxycodone Hydrochloride Oral Solution is Oxycodone Hydrochloride Oral Solution. There are no other listed brand versions of Oxycodone Hydrochloride Oral Solution.

What is the NDC code for Oxycodone Hydrochloride Oral Solution 100 mg/5mL?

The NDC (National Drug Code) for Oxycodone Hydrochloride Oral Solution 100 mg/5mL is 13107-262, listed by Aurolife Pharma, LLC.

Product NDC

13107-262

Package NDC

13107-262-57

Other Oxycodone Hydrochloride Oral Solution Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)