Medications & Supplements/Prescription Drugs

Hydrocodone and Acetaminophen Tablets Recalled for Product Mix-up

Agency Publication Date: December 7, 2021

Summary

Ascent Pharmaceuticals, Inc. is recalling approximately 9,744 bottles of Hydrocodone Bitartrate and Acetaminophen (10 mg/325 mg) tablets due to a product mix-up. The tablets, which are used for pain management, were sold in 100-count bottles under the Camber Pharmaceuticals brand name. No incidents or injuries have been reported to date regarding this issue.

Risk

A product mix-up means a bottle may contain the wrong medication or the wrong dosage strength. This could lead to patients receiving unintended medication, resulting in either a lack of pain relief or potential adverse side effects from the incorrect drug.

What You Should Do

This recall affects 100-count bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, manufactured for Camber Pharmaceuticals, Inc. (NDC 31722-997-01).
Check your prescription bottle label for lot number 21070817 with an expiration date of June 2023 (Exp 6/2023).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg (100-count bottle)by Camber Pharmaceuticals

Variants: 10 mg/325 mg, Tablet, Rx only

Lot Numbers:

21070817 (Exp 6/2023)

NDC:

31722-997-01

Manufactured for Camber Pharmaceuticals, Inc. by Ascent Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89060

Status: Resolved

Manufacturer: Ascent Pharmaceuticals, Inc.

Sold By: Camber Pharmaceuticals, Inc.

Manufactured In: United States

Units Affected: 9744 bottles

Distributed To: Nationwide

Agency Last Updated: December 17, 2021

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 100-count bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, manufactured for Camber Pharmaceuticals, Inc. (NDC 31722-997-01).

Check your prescription bottle label for lot number 21070817 with an expiration date of June 2023 (Exp 6/2023).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.