Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Industries, Inc.: Atorvastatin Calcium Tablets Recalled for Latex Glove Foreign Matter

Agency Publication Date: March 19, 2020

Summary

Sun Pharmaceutical Industries, Inc. is recalling 1,416 bottles of Atorvastatin Calcium Tablets USP 40 mg (generic Lipitor) because a piece of a latex glove was found inside a bottle from one specific lot. This medication is used to treat high cholesterol and prevent heart disease. If you have this product, you should contact your doctor or pharmacist immediately to discuss your treatment and arrange for a replacement. Do not stop taking your medication without consulting a healthcare professional first.

Risk

The presence of a latex glove fragment in the medication bottle poses a risk of allergic reactions to patients with latex sensitivities and could potentially lead to contamination of the tablets.

What You Should Do

Check your medication bottle for Atorvastatin Calcium Tablets USP 40 mg in a 500-count bottle with NDC 63304-829-05.
Verify if your bottle belongs to Lot AA33617 with an expiration date of 03/2021.
If you have the affected lot, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to ensure your treatment is not interrupted.
Return any unused tablets from the affected lot to your pharmacy for a refund.
Contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 for more information 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

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: Atorvastatin Calcium Tablets, USP 40 mg (500-count bottle)

Model:

NDC 63304-829-05

D-1047-2020

Lot Numbers:

AA33617 (Exp 03/2021)

Date Ranges: Exp 03/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85184

Status: Resolved

Manufacturer: Sun Pharmaceutical Industries, Inc.

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 1416 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 Atorvastatin Calcium Tablets USP 40 mg in a 500-count bottle with NDC 63304-829-05.

Verify if your bottle belongs to Lot AA33617 with an expiration date of 03/2021.

If you have the affected lot, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to ensure your treatment is not interrupted.

Return any unused tablets from the affected lot to your pharmacy for a refund.

Contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 for more information 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.