Medications & Supplements/Prescription Drugs

Direct Rx: Nortriptyline HCL Capsules Recalled Due to Manufacturing Deviations

Agency Publication Date: March 12, 2021

Summary

Direct Rx is recalling 17 bottles of Nortriptyline HCL (10 mg) capsules, a prescription medication used to treat depression. The recall was initiated because the active ingredient used in this specific batch was sourced from an alternate supplier and used before the manufacturing site had formally qualified that supplier for use. This deviation from Current Good Manufacturing Practice (cGMP) standards means the quality and consistency of the ingredient were not fully verified prior to production.

Risk

Using an unverified active ingredient can lead to inconsistent drug potency or the presence of unexpected impurities, which may reduce the medication's effectiveness or cause unforeseen side effects.

What You Should Do

Check your prescription bottle for Nortriptyline HCL capsules (10 mg), packaged in 30-count bottles with NDC 6191985330.
Verify if your bottle matches Lot# 28DE2002 with an expiration date of 10/31/22.
Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking the medication or if you need a replacement prescription.
Return any unused capsules from the affected lot to your pharmacy for a refund.
Contact Direct Rx at their Dawsonville, GA location (706-216-1166) for further instructions regarding this recall.
For additional questions or to report adverse effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Nortriptyline HCL capsules, 10 mg (30-count bottle)

Model:

NDC 6191985330

Recall #: D-0300-2021

Lot Numbers:

28DE2002 (Exp 10/31/22)

Date Ranges: 10/31/22

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87458

Status: Resolved

Manufacturer: Direct Rx

Sold By: Direct Rx

Manufactured In: United States

Units Affected: 17 bottles

Distributed To: Georgia

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

Check your prescription bottle for Nortriptyline HCL capsules (10 mg), packaged in 30-count bottles with NDC 6191985330.

Verify if your bottle matches Lot# 28DE2002 with an expiration date of 10/31/22.

Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking the medication or if you need a replacement prescription.

Return any unused capsules from the affected lot to your pharmacy for a refund.

Contact Direct Rx at their Dawsonville, GA location (706-216-1166) for further instructions regarding this recall.

For additional questions or to report adverse effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.