Medications & Supplements/Prescription Drugs

American Health Packaging Oxycodone Hydrochloride Oral Solution Recalled

Agency Publication Date: March 11, 2022

Summary

American Health Packaging has recalled 89,880 unit-dose cups of Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL (5 mL per cup). This medication, used for pain management, is being recalled because of an impurity failure discovered at the time of repackaging. No injuries or adverse events have been reported to date, and the product was distributed nationwide to hospitals, clinics, and other institutional healthcare providers.

Risk

The presence of impurities in medication can compromise its safety and quality, potentially leading to unintended side effects or reduced treatment effectiveness for patients.

What You Should Do

This recall affects Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, distributed in unit-dose cups by American Health Packaging. The affected cups are from lot 1004276 with an expiration date of 11/30/2022.
Identify affected products by checking for Unit Dose NDC 60687-406-40 or Case NDC 60687-406-77 on the packaging. The unit-dose cups are delivered in trays of 10 cups and were sold exclusively for institutional use.
Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL

Variants: 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Institutional Use Only

Lot Numbers:

1004276 (Exp 11/30/2022)

NDC:

60687-406-77

60687-406-40

GTIN:

00360687406404

Recalled due to impurity failure at 0-time of the repackaged lot.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89670

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Hospitals; Clinics; Institutional healthcare providers

Manufactured In: United States

Units Affected: 89,880 unit-dose cups

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, distributed in unit-dose cups by American Health Packaging. The affected cups are from lot 1004276 with an expiration date of 11/30/2022.

Identify affected products by checking for Unit Dose NDC 60687-406-40 or Case NDC 60687-406-77 on the packaging. The unit-dose cups are delivered in trays of 10 cups and were sold exclusively for institutional use.

Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Affected Products

Product: Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL

Variants: 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Institutional Use Only

Lot Numbers:

1004276 (Exp 11/30/2022)

NDC:

60687-406-77

60687-406-40

GTIN:

00360687406404

Recalled due to impurity failure at 0-time of the repackaged lot.