Medications & Supplements/Prescription Drugs

Glenmark Pharmaceuticals Inc., USA: Pravastatin Sodium Tablets Recalled Due to Presence of a Foreign Tablet

Agency Publication Date: April 10, 2019

Summary

Glenmark Pharmaceuticals Inc., USA is recalling approximately 2,076 bottles of Pravastatin Sodium (20 mg), a prescription medication used to treat high cholesterol. The recall was initiated after a foreign tablet was discovered inside a sealed 500-count bottle of the medication. Taking an unknown medication instead of your prescribed dose could lead to unexpected side effects or a failure to manage your cholesterol levels. Consumers should check their prescription bottles immediately to see if their medication is part of this affected batch.

Risk

The presence of a foreign tablet in the bottle poses a risk of accidental ingestion of an incorrect medication. This could cause serious adverse health effects depending on the identity of the foreign tablet and the patient's underlying health conditions.

What You Should Do

Check your prescription bottle of Pravastatin Sodium Tablets (20 mg) for Lot number 17181491 with an expiration date of August 2021.
Verify the National Drug Code (NDC) 68462-196-05 and the quantity (500-count bottle) printed on the label to confirm if your medication is affected.
If you identify an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on how to proceed with your treatment.
Return any unused portions of the affected medication to your pharmacy for a refund and to ensure the product is properly handled.
Contact Glenmark Pharmaceuticals Inc., USA at 1-888-723-3332 for further instructions regarding this recall.
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 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 (20 mg, 500-count bottle)

Model:

NDC 68462-196-05

Recall #: D-1120-2019

Lot Numbers:

17181491 (Exp. Aug. 2021)

Date Ranges: Expiration Date: August 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82461

Status: Resolved

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 2076 500-count Bottles

Distributed To: Nationwide

Agency Last Updated: April 11, 2019

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 prescription bottle of Pravastatin Sodium Tablets (20 mg) for Lot number 17181491 with an expiration date of August 2021.

Verify the National Drug Code (NDC) 68462-196-05 and the quantity (500-count bottle) printed on the label to confirm if your medication is affected.

If you identify an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on how to proceed with your treatment.

Return any unused portions of the affected medication to your pharmacy for a refund and to ensure the product is properly handled.

Contact Glenmark Pharmaceuticals Inc., USA at 1-888-723-3332 for further instructions regarding this recall.

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