Medications & Supplements/Prescription Drugs

Graviti Pharmaceuticals Private Limited: Atorvastatin (Lipitor) Recalled for Potential 20mg Tablet in 10mg Bottles

Agency Publication Date: February 6, 2020

Summary

Graviti Pharmaceuticals is recalling 29,056 bottles of Atorvastatin Calcium Tablets (the generic version of Lipitor) after a customer found a 20 mg tablet inside a bottle labeled for 10 mg tablets. This recall affects 90-count bottles of the 10 mg dose sold nationwide in the United States. Taking a higher dose of medication than prescribed can lead to unintended side effects or medical complications, and the company is voluntarily recalling these bottles to prevent potential health risks.

Risk

A consumer may accidentally ingest double their prescribed dose of cholesterol medication if they consume the foreign 20 mg tablet found in the 10 mg bottle. While no injuries have been reported, taking a higher dose of Atorvastatin can increase the risk of side effects such as muscle pain or liver issues.

What You Should Do

Check your medication bottle for Atorvastatin Calcium Tablets, USP, 10 mg (90-count) with NDC 70377-027-11.
Verify the specific lot and expiration date on the label: look for Lot # ATA318099C with an expiration date of 12/2020.
Visually inspect your tablets; if you notice any tablets that appear different in size or marking than the others in your 10 mg bottle, do not consume them.
Contact your healthcare provider or pharmacist immediately to discuss your prescription and ensure you have the correct dosage.
Return any unused product from the affected lot to your pharmacy for a refund and contact Graviti Pharmaceuticals 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

Healthcare consultation and pharmacy return

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, 10 mg (90-count bottle)

Model:

NDC 70377-027-11

Recall #: D-0832-2020

Lot Numbers:

ATA318099C (Exp 12/2020)

Date Ranges: Expiration 12/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84814

Status: Resolved

Manufacturer: Graviti Pharmaceuticals Private Limited

Sold By: pharmacies

Manufactured In: India

Units Affected: 29,056 bottles

Distributed To: Nationwide

Agency Last Updated: February 7, 2020

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

Risk

What You Should Do

Check your medication bottle for Atorvastatin Calcium Tablets, USP, 10 mg (90-count) with NDC 70377-027-11.

Verify the specific lot and expiration date on the label: look for Lot # ATA318099C with an expiration date of 12/2020.

Visually inspect your tablets; if you notice any tablets that appear different in size or marking than the others in your 10 mg bottle, do not consume them.

Contact your healthcare provider or pharmacist immediately to discuss your prescription and ensure you have the correct dosage.

Return any unused product from the affected lot to your pharmacy for a refund and contact Graviti Pharmaceuticals 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.