Medications & Supplements/Prescription Drugs

Glenmark Pravastatin Sodium Tablets Recalled for Failed Dissolution

Agency Publication Date: July 18, 2024

Summary

Glenmark Pharmaceuticals Inc., USA is recalling 147,168 bottles of Pravastatin Sodium (80mg) tablets because the product failed dissolution testing. This means the tablets may not dissolve properly or release the active medication into the body as required. The recall affects 90-count and 500-count bottles of this cholesterol-lowering medication that were distributed nationwide throughout the United States.

Risk

If the tablets do not dissolve correctly, the medication may not be effectively absorbed into the bloodstream, potentially making the treatment less effective at lowering cholesterol. No reports of injuries or adverse events were mentioned in the recall notice.

What You Should Do

The recalled products are 90-count and 500-count bottles of Pravastatin Sodium Tablets, USP 80mg, sold under the Glenmark brand.
Check your medication bottle for NDC codes 68462-198-90 or 68462-198-05 and lot numbers such as 17211249, 17211525, 17220053, or 17211290 with expiration dates ranging from June 2024 to January 2025. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Pravastatin Sodium Tablets, USP 80mg (90-count bottle)by Glenmark

Variants: 80 mg, 90-count bottle, Tablet

Lot Numbers:

17211249 (Exp 6/30/24)

17211264 (Exp 6/30/24)

17211266 (Exp 6/30/24)

17211286 (Exp 6/30/24)

17211525 (Exp 7/31/24)

17211535 (Exp 7/31/24)

17211549 (Exp 7/31/24)

17211787 (Exp 8/31/24)

17211801 (Exp 8/31/24)

17212041 (Exp 9/30/24)

17212088 (Exp 10/31/24)

17212106 (Exp 10/31/24)

17212346 (Exp 11/30/24)

17212345 (Exp 11/30/24)

17220053 (Exp 12/31/24)

17220054 (Exp 12/31/24)

17220055 (Exp 12/31/24)

17220309 (Exp 1/31/25)

17220310 (Exp 1/31/25)

NDC:

68462-198-90

Product: Pravastatin Sodium Tablets, USP 80mg (500-count bottle)by Glenmark

Variants: 80 mg, 500-count bottle, Tablet

Lot Numbers:

17211290 (Exp 6/30/2024)

NDC:

68462-198-05

Product Images

Label, Glenmark Potassium Chloride Extended Release 750mg Capsules, 100 count

Label, Glenmark Potassium Chloride Extended Release 750mg Capsules, 500 count

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94899

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies; Drugstores

Manufactured In: India

Units Affected: a) 145,800 bottles; b) 1,368 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 · FDA Press Release · 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

The recalled products are 90-count and 500-count bottles of Pravastatin Sodium Tablets, USP 80mg, sold under the Glenmark brand.

Check your medication bottle for NDC codes 68462-198-90 or 68462-198-05 and lot numbers such as 17211249, 17211525, 17220053, or 17211290 with expiration dates ranging from June 2024 to January 2025. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Pravastatin Sodium Tablets, USP 80mg (90-count bottle)by Glenmark

Variants: 80 mg, 90-count bottle, Tablet

Lot Numbers:

17211249 (Exp 6/30/24)

17211264 (Exp 6/30/24)

17211266 (Exp 6/30/24)

17211286 (Exp 6/30/24)

17211525 (Exp 7/31/24)

17211535 (Exp 7/31/24)

17211549 (Exp 7/31/24)

17211787 (Exp 8/31/24)

17211801 (Exp 8/31/24)

17212041 (Exp 9/30/24)

17212088 (Exp 10/31/24)

17212106 (Exp 10/31/24)

17212346 (Exp 11/30/24)

17212345 (Exp 11/30/24)

17220053 (Exp 12/31/24)

17220054 (Exp 12/31/24)

17220055 (Exp 12/31/24)

17220309 (Exp 1/31/25)

17220310 (Exp 1/31/25)

NDC:

68462-198-90

Product: Pravastatin Sodium Tablets, USP 80mg (500-count bottle)by Glenmark

Variants: 80 mg, 500-count bottle, Tablet

Lot Numbers:

17211290 (Exp 6/30/2024)

NDC:

68462-198-05