Medications & Supplements/Prescription Drugs

International Laboratories, Inc.: Pravastatin Sodium Tablets Recalled Due to Mislabeling and Drug Mix-up

Agency Publication Date: December 1, 2017

Summary

International Laboratories, Inc. is recalling approximately 82,056 bottles of Pravastatin Sodium (pravastatin) tablets, USP, 40 mg. The recall was issued because the bottles were found to contain Bupropion hydrochloride XL (bupropion) 300 mg tablets instead of the labeled cholesterol medication. These products were sold in 30-count bottles across the United States and Puerto Rico. Consumers who take the incorrect medication may experience serious side effects or a lack of treatment for their intended condition.

Risk

Taking Bupropion hydrochloride XL instead of Pravastatin Sodium can lead to serious health risks, including an increased risk of seizures or suicidal thoughts in some patients. Additionally, patients would not be receiving their intended cholesterol-lowering medication, which could impact their long-term cardiovascular health.

What You Should Do

Immediately check your medication bottle to see if it is Pravastatin Sodium Tablets, USP, 40 mg, in a 30-count bottle with NDC 54458-925-16.
Check the bottle for Lot Number 115698A with an expiration date of 02/19 (February 2019).
If your bottle matches this lot number, stop taking the medication immediately as it may contain Bupropion hydrochloride XL 300 mg instead of the labeled drug.
Contact your healthcare provider or pharmacist immediately to discuss your health and obtain a correct replacement prescription.
Return any unused tablets and the original bottle to the pharmacy where you purchased them for a refund.
Contact International Laboratories, Inc. at their facility in St. Petersburg, Florida, for further instructions 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 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 Tablets, USP, 40 mg (30-count bottle)

Model:

NDC 54458-925-16

Recall #: D-0102-2018

Lot Numbers:

115698A (Exp 02/19)

Date Ranges: Expiration Date 02/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77899

Status: Resolved

Manufacturer: International Laboratories, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 82056 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

Risk

What You Should Do

Immediately check your medication bottle to see if it is Pravastatin Sodium Tablets, USP, 40 mg, in a 30-count bottle with NDC 54458-925-16.

Check the bottle for Lot Number 115698A with an expiration date of 02/19 (February 2019).

If your bottle matches this lot number, stop taking the medication immediately as it may contain Bupropion hydrochloride XL 300 mg instead of the labeled drug.

Contact your healthcare provider or pharmacist immediately to discuss your health and obtain a correct replacement prescription.

Return any unused tablets and the original bottle to the pharmacy where you purchased them for a refund.

Contact International Laboratories, Inc. at their facility in St. Petersburg, Florida, for further instructions 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.