Medications & Supplements/Prescription Drugs

International Laboratories, Inc.: Pravastatin Sodium Tablets Recalled for Potential Dosage Mix-Up

Agency Publication Date: January 24, 2018

Summary

International Laboratories, Inc. has recalled 22,455 cartons of Pravastatin Sodium (USP) 10 mg and 20 mg tablets because some bottles may contain both dosages in the same container. This medication is used to treat high cholesterol and prevent cardiovascular disease. The recall affects 30-count bottles sold nationwide between 2018 and 2019, potentially leading to patients taking double or half of their prescribed dose. Consumers should consult their healthcare provider to discuss their treatment and how to identify the correct tablets.

Risk

Taking the 20 mg tablet instead of the 10 mg tablet could lead to an unintended higher dose, increasing the risk of side effects like muscle pain or liver issues, while taking a 10 mg tablet instead of a 20 mg tablet could result in under-treatment of cholesterol levels.

What You Should Do

Check your medication bottles for Pravastatin Sodium Tablets, USP, 10 mg (NDC 54458-927-16) with lot number 117093A and expiration date 06/19.
Check your medication bottles for Pravastatin Sodium Tablets, USP, 20 mg (NDC 54458-926-16) with lot number 117103A and expiration date 03/19.
Visually inspect the tablets in your bottle to ensure they all look identical; if you see two different types of tablets in the same bottle, do not consume them.
Contact your healthcare provider or pharmacist immediately for guidance on your prescription and to ensure you are taking the correct dosage.
Return any unused or affected product to your pharmacy to receive a refund and secure a correct replacement.
Contact International Laboratories, Inc. at their facility in Seminole, Florida, for further instructions regarding this voluntary recall.
For additional questions or to report a complaint, 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

Pharmacy refund and healthcare consultation

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, 10 mg (30-count bottles)

Model:

NDC 54458-927-16

Recall #: D-0233-2018

Lot Numbers:

117093A (Exp. 06/19)

Date Ranges: Expiration 06/19

Product: Pravastatin Sodium Tablets, USP, 20 mg (30-count bottles)

Model:

NDC 54458-926-16

Recall #: D-0234-2018

Lot Numbers:

117103A (Exp. 03/19)

Date Ranges: Expiration 03/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78939

Status: Resolved

Manufacturer: International Laboratories, Inc.

Sold By: Pharmacy dispensers; Retail pharmacies

Manufactured In: United States

Units Affected: 2 products (9,052 cartons; 13,403 cartons)

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 bottles for Pravastatin Sodium Tablets, USP, 10 mg (NDC 54458-927-16) with lot number 117093A and expiration date 06/19.

Check your medication bottles for Pravastatin Sodium Tablets, USP, 20 mg (NDC 54458-926-16) with lot number 117103A and expiration date 03/19.

Visually inspect the tablets in your bottle to ensure they all look identical; if you see two different types of tablets in the same bottle, do not consume them.

Contact your healthcare provider or pharmacist immediately for guidance on your prescription and to ensure you are taking the correct dosage.

Return any unused or affected product to your pharmacy to receive a refund and secure a correct replacement.

Contact International Laboratories, Inc. at their facility in Seminole, Florida, for further instructions regarding this voluntary recall.

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

Affected Products

Product: Pravastatin Sodium Tablets, USP, 10 mg (30-count bottles)

Model:

NDC 54458-927-16

Recall #: D-0233-2018

Lot Numbers:

117093A (Exp. 06/19)

Date Ranges: Expiration 06/19

Product: Pravastatin Sodium Tablets, USP, 20 mg (30-count bottles)

Model:

NDC 54458-926-16

Recall #: D-0234-2018

Lot Numbers:

117103A (Exp. 03/19)

Date Ranges: Expiration 03/19