Medications & Supplements/Prescription Drugs

AVKARE Inc.: Mesalamine Delayed-Release Tablets Recalled for Failing Dissolution Tests

Agency Publication Date: November 6, 2020

Summary

AVKARE Inc. is recalling 15,678 bottles of Mesalamine (mesalamine) Delayed-Release Tablets, USP 1.2 gram (Once-Daily) because the medication failed to meet dissolution specifications during testing. This failure means the tablets may not dissolve properly in the body as intended, which could prevent the patient from receiving the full therapeutic dose of the medication. The affected products were distributed nationwide in 120-count bottles and were manufactured for AvKARE, Inc. in Pulaski, Tennessee.

Risk

If the medication does not dissolve according to specifications, it may not be absorbed correctly, leading to a decrease in effectiveness for treating conditions like ulcerative colitis. This could result in a return or worsening of inflammatory bowel symptoms.

What You Should Do

Check your medication bottle for the product name 'Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily)' and NDC number 42291-564-12.
Locate the lot number and expiration date on the side of the bottle. Affected lots include: 26085 (Exp. 07/2021), 26426 (Exp. 01/2022), 26983 (Exp. 04/2022), and 28647 (Exp. 06/2022).
If your bottle matches any of the affected lot numbers, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to obtain a replacement.
Return any unused medication from the recalled lots to the pharmacy where you purchased it for a refund.
Contact AVKARE Inc. at their Pulaski, Tennessee headquarters for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and refund

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

Affected Products

Product: Mesalamine Delayed-Release Tablets, USP 1.2 gram (120 Tablets bottle)

Model:

NDC 42291-564-12

Lot Numbers:

26085 (Exp. 07/2021)

26426 (Exp. 01/2022)

26983 (Exp. 04/2022)

28647 (Exp. 06/2022)

Date Ranges: Exp. 07/2021, Exp. 01/2022, Exp. 04/2022, Exp. 06/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86695

Status: Resolved

Manufacturer: AVKARE Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 15,678 bottles

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

Check your medication bottle for the product name 'Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily)' and NDC number 42291-564-12.

Locate the lot number and expiration date on the side of the bottle. Affected lots include: 26085 (Exp. 07/2021), 26426 (Exp. 01/2022), 26983 (Exp. 04/2022), and 28647 (Exp. 06/2022).

If your bottle matches any of the affected lot numbers, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to obtain a replacement.

Return any unused medication from the recalled lots to the pharmacy where you purchased it for a refund.

Contact AVKARE Inc. at their Pulaski, Tennessee headquarters for further instructions regarding this recall.

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