Medications & Supplements/Prescription Drugs

Strides Pharma Inc.: Potassium Chloride Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: October 8, 2021

Summary

Strides Pharma Inc. is recalling 1,813 bottles of Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg) because the medication failed dissolution specifications. This defect means the tablets may not release the medication into the body as intended, which can impact the effectiveness of the treatment. These prescription tablets were distributed nationwide in 500-count bottles. If you have this medication, you should contact your healthcare provider or pharmacist for guidance on how to proceed with your treatment.

Risk

The tablets failed testing for how quickly the medication dissolves in the body; if a drug does not dissolve properly, it may not be absorbed correctly, leading to either too much or too little medication entering the bloodstream.

What You Should Do

Identify if you have the affected product by checking the bottle for Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500-count bottles, with NDC 64380-861-07.
Check the label for lot number 7240840A with an expiration date of 12/31/2021.
If you have this specific lot, contact your healthcare provider or pharmacist immediately to discuss a replacement and ensure your treatment is not interrupted.
Return any unused tablets from this lot to your pharmacy for a refund and further instructions.
Contact Strides Pharma Inc. at their East Brunswick, NJ location if you have additional questions regarding this recall.
For further information or to report a problem, contact the FDA Consumer Complaint line 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 return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets

Model:

NDC 64380-861-07

Recall #: D-0006-2022

Lot Numbers:

7240840A (Exp 12/31/2021)

Date Ranges: 12/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88759

Status: Resolved

Manufacturer: Strides Pharma Inc.

Sold By: pharmacies nationwide

Manufactured In: India, United States

Units Affected: 1813 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

What You Should Do

Identify if you have the affected product by checking the bottle for Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500-count bottles, with NDC 64380-861-07.

Check the label for lot number 7240840A with an expiration date of 12/31/2021.

If you have this specific lot, contact your healthcare provider or pharmacist immediately to discuss a replacement and ensure your treatment is not interrupted.

Return any unused tablets from this lot to your pharmacy for a refund and further instructions.

Contact Strides Pharma Inc. at their East Brunswick, NJ location if you have additional questions regarding this recall.

For further information or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.