Medications & Supplements/Prescription Drugs

Macleods Pharma Usa Inc: Montelukast Sodium Chewable Tablets Recalled for Failed Quality Testing

Agency Publication Date: January 24, 2020

Summary

Macleods Pharma USA, Inc. has voluntarily recalled 10,680 bottles of Montelukast Sodium Chewable Tablets (5 mg), a prescription medication used to treat asthma and allergies. This recall was initiated because quality testing revealed that one lot of the product did not meet dissolution specifications, meaning the medication may not dissolve properly in the body. The affected product was distributed nationwide in 90-count bottles and includes both the brand and generic identifiers for Montelukast Sodium.

Risk

The failure to meet dissolution specifications means the medication may not release its active ingredient at the required rate. This could potentially reduce the effectiveness of the drug in managing asthma or allergy symptoms for the patient.

What You Should Do

Check your prescription bottle to see if you have Montelukast Sodium Chewable Tablets, 5 mg, in 90-count bottles with NDC 33342-111-10.
Verify the lot number and expiration date on the label; the affected product is lot BMD8901B with an expiration date of 02/2021.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you should continue taking the medication from this specific lot.
Return any unused tablets from the affected lot to your pharmacy for a refund and to obtain a replacement supply.
Contact Macleods Pharma USA, Inc. for further instructions or questions regarding this recall.
For additional information, 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: Montelukast Sodium Chewable Tablets, 5 mg (90-count bottle)

Model:

NDC 33342-111-10

Recall #: D-0823-2020

Lot Numbers:

BMD8901B (Exp. Date 02/2021)

Date Ranges: February 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84749

Status: Resolved

Manufacturer: Macleods Pharma Usa Inc

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 10680 units

Distributed To: Nationwide

Agency Last Updated: January 31, 2020

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 to see if you have Montelukast Sodium Chewable Tablets, 5 mg, in 90-count bottles with NDC 33342-111-10.

Verify the lot number and expiration date on the label; the affected product is lot BMD8901B with an expiration date of 02/2021.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you should continue taking the medication from this specific lot.

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

Contact Macleods Pharma USA, Inc. for further instructions or questions regarding this recall.

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