Medications & Supplements/Prescription Drugs

Ascend Laboratories LLC: Tizanidine (Zanaflex) Tablets Recalled for Failed Dissolution Tests

Agency Publication Date: December 3, 2020

Summary

Ascend Laboratories LLC is recalling 1,200 bottles of Tizanidine Tablets, USP 4mg, a prescription medication used to manage muscle spasms. The recall was initiated because the tablets failed dissolution testing, which means they did not dissolve properly or quickly enough. This quality issue can prevent the medication from working effectively for the patient. Consumers should check if they have 150-count bottles of this medication from the affected lot distributed in Michigan.

Risk

If the medication fails to dissolve as intended, the body may not absorb the correct amount of the drug at the right time. This can lead to a decrease in the effectiveness of the treatment, potentially causing muscle spasms or symptoms to return or worsen.

What You Should Do

Check your prescription bottle label for Tizanidine Tablets, USP 4mg (150 tablets per bottle) with NDC 67877-614-15.
Identify if your bottle is from Lot #19143017 with an expiration date of 05/31/2021.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you have been affected by this recall.
Return any unused tablets from the affected lot to your pharmacy for a refund and to obtain a replacement prescription.
Contact the manufacturer, Ascend Laboratories LLC, at their Parsippany, NJ office for further information regarding this recall.
For additional consumer safety questions, 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

Refund and medical guidance

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

Affected Products

Product: Tizanidine Tablets, USP 4mg (150 Tablets per Bottle)

Model:

NDC: 67877-614-15

Recall #: D-0173-2021

Lot Numbers:

19143017 (Exp. 05/31/2021)

Date Ranges: Exp. 05/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86859

Status: Resolved

Manufacturer: Ascend Laboratories LLC

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 1200 bottles

Distributed To: Michigan

Agency Last Updated: December 22, 2020

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 label for Tizanidine Tablets, USP 4mg (150 tablets per bottle) with NDC 67877-614-15.

Identify if your bottle is from Lot #19143017 with an expiration date of 05/31/2021.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you have been affected by this recall.

Return any unused tablets from the affected lot to your pharmacy for a refund and to obtain a replacement prescription.

Contact the manufacturer, Ascend Laboratories LLC, at their Parsippany, NJ office for further information regarding this recall.

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