Medications & Supplements/Prescription Drugs

Macleods Pharma Usa Inc: Tamsulosin Hydrochloride Capsules Recalled for Failed Dissolution Specifications

Agency Publication Date: August 9, 2019

Summary

Macleods Pharma USA, Inc. has recalled approximately 6,578 bottles of Tamsulosin Hydrochloride Capsules, USP 0.4 mg, which is used to treat symptoms of an enlarged prostate. The recall was initiated because the medication failed dissolution specifications, meaning the drug may not dissolve properly in the body as intended. This defect can prevent the medication from being absorbed correctly, potentially reducing its effectiveness for patients.

Risk

If the capsules do not dissolve according to specifications, the patient may receive an incorrect dose or the medication may not work at all, leading to a lack of symptom relief. No specific injuries or incidents have been reported in the recall data.

What You Should Do

Check your prescription bottle for 'Tamsulosin Hydrochloride Capsules, USP 0.4 mg' and match the NDC numbers and lot information.
For 100-count bottles (NDC 33342-159-11), look for lot BTP803A with an expiration date of 08/2020.
For 500-count bottles (NDC 33342-159-15), look for lot BTP802A (Exp 07/2020) or lot BTP901A (Exp 12/2020).
For 1000-count bottles (NDC 33342-159-44), look for lot BTP802B with an expiration date of 07/2020.
Contact your healthcare provider or pharmacist immediately for guidance if you find your medication is part of this recall. Do not stop taking your medication without consulting a professional first.
Return any unused product to your pharmacy for a refund and contact Macleods Pharma USA, Inc. for further instructions.
For additional 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

Contact healthcare provider and return product.

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

Affected Products

Product: Tamsulosin Hydrochloride Capsules, USP 0.4 mg (100-count)

Model:

NDC 33342-159-11

Lot Numbers:

BTP803A (Exp 08/2020)

Date Ranges: Exp 08/2020

Product: Tamsulosin Hydrochloride Capsules, USP 0.4 mg (500-count)

Model:

NDC 33342-159-15

Lot Numbers:

BTP802A (Exp 07/2020)

BTP901A (Exp 12/2020)

Date Ranges: Exp 07/2020, Exp 12/2020

Product: Tamsulosin Hydrochloride Capsules, USP 0.4 mg (1000-count)

Model:

NDC 33342-159-44

Lot Numbers:

BTP802B (Exp 07/2020)

Date Ranges: Exp 07/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83414

Status: Resolved

Manufacturer: Macleods Pharma Usa Inc

Sold By: Pharmacies

Manufactured In: United States, India

Units Affected: a) 5448 bottles b) 972 bottles c) 158 bottles

Distributed To: Nationwide

Agency Last Updated: August 28, 2019

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 'Tamsulosin Hydrochloride Capsules, USP 0.4 mg' and match the NDC numbers and lot information.

For 100-count bottles (NDC 33342-159-11), look for lot BTP803A with an expiration date of 08/2020.

For 500-count bottles (NDC 33342-159-15), look for lot BTP802A (Exp 07/2020) or lot BTP901A (Exp 12/2020).

For 1000-count bottles (NDC 33342-159-44), look for lot BTP802B with an expiration date of 07/2020.

Contact your healthcare provider or pharmacist immediately for guidance if you find your medication is part of this recall. Do not stop taking your medication without consulting a professional first.

Return any unused product to your pharmacy for a refund and contact Macleods Pharma USA, Inc. for further instructions.

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

Affected Products

Product: Tamsulosin Hydrochloride Capsules, USP 0.4 mg (100-count)

Model:

NDC 33342-159-11

Lot Numbers:

BTP803A (Exp 08/2020)

Date Ranges: Exp 08/2020

Product: Tamsulosin Hydrochloride Capsules, USP 0.4 mg (500-count)

Model:

NDC 33342-159-15

Lot Numbers:

BTP802A (Exp 07/2020)

BTP901A (Exp 12/2020)

Date Ranges: Exp 07/2020, Exp 12/2020

Product: Tamsulosin Hydrochloride Capsules, USP 0.4 mg (1000-count)

Model:

NDC 33342-159-44

Lot Numbers:

BTP802B (Exp 07/2020)

Date Ranges: Exp 07/2020