Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Clopidogrel Tablets Recalled Due to Failed Dissolution Testing

Agency Publication Date: November 20, 2018

Summary

Dr. Reddy's Laboratories, Inc. is voluntarily recalling 4,212 units of Clopidogrel (300 mg) tablets, a prescription blood thinner used to prevent heart attacks and strokes. This recall was initiated after routine stability testing at the 18-month mark showed the tablets were not dissolving properly. When a medication fails to dissolve according to specifications, it may not be absorbed correctly by the body, which can impact how well the treatment works.

Risk

If the medication does not dissolve properly, the patient may not receive the intended dose of the drug, potentially increasing the risk of blood clots, heart attack, or stroke. No specific injuries or adverse events have been reported in this recall notification.

What You Should Do

Check your medication packaging for Clopidogrel Tablets, USP, 300 mg in 30-count blister packs (5 x 6 unit-dose) with NDC 55111-671-31.
Verify if your medication belongs to Lot Number T600530 with an expiration date of 11/18 (November 2018).
If you have the affected medication, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.
Return any unused portions of the affected lot to your pharmacy for a refund and further instructions.
Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office if you have specific questions regarding this recall.
For additional questions or to report a problem, 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

Pharmaceutical product 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: Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack

Model:

NDC 55111-671-31

Recall #: D-0283-2019

Lot Numbers:

T600530 (Exp 11/18)

Date Ranges: 11/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81530

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 4,212 (30-count blister pack)

Distributed To: Nationwide

Agency Last Updated: November 27, 2018

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 packaging for Clopidogrel Tablets, USP, 300 mg in 30-count blister packs (5 x 6 unit-dose) with NDC 55111-671-31.

Verify if your medication belongs to Lot Number T600530 with an expiration date of 11/18 (November 2018).

If you have the affected medication, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.

Return any unused portions of the affected lot to your pharmacy for a refund and further instructions.

Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office if you have specific questions regarding this recall.

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