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Class III: unlikely to cause harmTerminated

Akorn Oxycodone Hydrochloride Oral Solution Recall

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx o…

Akorn, Inc. · Lake Forest, IL

Risk level
Class III
Reported by FDA
Jan 19, 2022
Recall ID
D-0368-2022
Check your lot numberHow we source this data

Summary

Akorn recalled Oxycodone Hydrochloride Oral Solution starting Dec 3, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0368-2022 on Jan 19, 2022. Reason: Labeling: Missing Label. Status: Terminated.

Why it was recalled

Labeling: Missing Label

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0368-2022
Classification
Class III
Status
Terminated
Recall initiated
Dec 3, 2021
FDA report date
Jan 19, 2022
Quantity
8184 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-0368-2022, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
89142
Address
1925 W Field Ct Ste 300
Code information
Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023
Postal code
60045-4862
Report date
Jan 19, 2022
Product type
Drugs
Recall number
D-0368-2022
Classification
Class III
Recalling firm
Akorn, Inc.
Product quantity
8184 bottles
Termination date
Aug 19, 2022
Reason for recall
Labeling: Missing Label
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide USA
Recall initiation date
Dec 3, 2021
Initial firm notification
Letter
Center classification date
Jan 13, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0368-2022, published Jan 19, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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