Medications & Supplements/Prescription Drugs

American Health Packaging Rifampin Capsules Recalled for Impurity Standards

Agency Publication Date: January 18, 2023

Summary

Amerisource Health Services LLC has recalled 3,091 cartons of American Health Packaging Rifampin Capsules USP, 300 mg. This prescription medication is used to treat various bacterial infections, including tuberculosis. The recall was issued because testing showed the capsules failed to meet standards for impurities and degradation levels. No incidents or injuries related to this issue have been reported at this time.

Risk

Medications that contain impurities or degradation products above approved levels may be less effective or could potentially cause unexpected side effects during treatment.

What You Should Do

This recall affects Rifampin Capsules USP (300 mg) sold in cartons containing 100 capsules (10 cards of 10) distributed by American Health Packaging.
Check your medication packaging for carton NDC 60687-586-01 or individual dose NDC 60687-586-11, and lot number 1007805 with an expiration date of 12/31/2023.
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 regarding this recall.

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: Rifampin Capsules USP (300 mg)

Variants: 300 mg, 100 Capsules (10 x 10) per carton

Lot Numbers:

1007805 (Exp 12/31/2023)

NDC:

60687-586-01

60687-586-11

Recall #: D-0165-2023; Distributed by American Health Packaging.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91416

Status: Resolved

Manufacturer: Amerisource Health Services LLC

Sold By: American Health Packaging

Manufactured In: United States

Units Affected: 3,091 cartons

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 Rifampin Capsules USP (300 mg) sold in cartons containing 100 capsules (10 cards of 10) distributed by American Health Packaging.

Check your medication packaging for carton NDC 60687-586-01 or individual dose NDC 60687-586-11, and lot number 1007805 with an expiration date of 12/31/2023.

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 regarding this recall.