Medications & Supplements/Prescription Drugs

Lupin Limited: Pravastatin Sodium Tablets Recalled Due to Foreign Capsule Contamination

Agency Publication Date: November 21, 2017

Summary

Lupin Limited is recalling one lot of Pravastatin Sodium Tablets USP (40 mg), a cholesterol-lowering medication, because a bottle was found to contain a single capsule of a different medication, Duloxetine Delayed Release (30 mg). Duloxetine is a prescription drug used to treat depression and anxiety; taking an unintended medication can lead to serious health complications or drug interactions. If you have this product, you should contact your healthcare provider or pharmacist immediately to discuss your treatment and how to obtain a safe replacement.

Risk

A pharmacy reported finding a 30mg Duloxetine capsule inside a 90-count bottle of 40mg Pravastatin tablets. Taking the wrong medication could cause unintended side effects or dangerous interactions with other drugs you may be taking.

What You Should Do

Check your medication bottle for Pravastatin Sodium USP, 40 mg, 90-count bottles with NDC 68180-487-09.
Verify if your bottle belongs to Lot # G702459 with an expiration date of February 2020 (Exp 2/20).
If your bottle matches this lot number, look inside for any capsules that do not match the standard tablet appearance; specifically, watch for a 30mg Duloxetine Delayed Release Capsule.
Contact your healthcare provider or pharmacist immediately for guidance if you believe you have taken the wrong medication or if you find a foreign capsule in your bottle.
Return any unused portions of the affected lot to your pharmacy for a refund and contact Lupin Pharmaceuticals, 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

Healthcare provider 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: Pravastatin Sodium USP Tablets, 40 mg (90-count bottle)

Model:

NDC 68180-487-09

Recall #: D-0092-2018

Lot Numbers:

G702459 (Exp 2/20)

Date Ranges: Exp 2/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78566

Status: Resolved

Manufacturer: Lupin Limited

Sold By: pharmacies

Manufactured In: India

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 Pravastatin Sodium USP, 40 mg, 90-count bottles with NDC 68180-487-09.

Verify if your bottle belongs to Lot # G702459 with an expiration date of February 2020 (Exp 2/20).

If your bottle matches this lot number, look inside for any capsules that do not match the standard tablet appearance; specifically, watch for a 30mg Duloxetine Delayed Release Capsule.

Contact your healthcare provider or pharmacist immediately for guidance if you believe you have taken the wrong medication or if you find a foreign capsule in your bottle.

Return any unused portions of the affected lot to your pharmacy for a refund and contact Lupin Pharmaceuticals, 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.