Medications & Supplements/Prescription Drugs

Strides Pharma Science Limited: Potassium Chloride Tablets Recalled for Oversized Tablets

Agency Publication Date: March 13, 2020

Summary

Strides Pharma Science Limited has recalled 2,576 bottles of Potassium Chloride Extended-Release Tablets (750mg) after oversized tablets were discovered in certain batches. Taking a tablet that is larger than intended could potentially result in an incorrect dosage or difficulty swallowing. These prescription medications were distributed nationwide in 1000-count bottles and were manufactured in India.

Risk

The presence of oversized tablets indicates a manufacturing defect that may lead to patients receiving more medication than prescribed or experiencing choking hazards. No specific injuries or adverse events have been reported in this notice, but the product failed to meet size and weight specifications.

What You Should Do

Locate your white plastic bottle of Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), containing 1000 tablets.
Check the bottle label for NDC 64380-861-08 and verify if your lot number and expiration date match the following: Lot 7238958A (Exp 7/31/2021), Lot 7238257A (Exp 7/31/2021), or Lot 7239404A (Exp 9/30/2021).
If your bottle matches any of the affected lot numbers, contact your healthcare provider or pharmacist immediately for guidance on whether to continue your treatment or obtain a replacement.
Return any unused or affected product to your pharmacy for a refund and to ensure the defective tablets are properly handled.
Contact the manufacturer, Strides Pharma Inc., 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

Pharmacy return 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: Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle

Model:

NDC 64380-861-08

Recall #: D-1029-2020

Lot Numbers:

7238958A (Exp 7/31/2021)

7238257A (Exp 7/31/2021)

7239404A (Exp 9/30/2021)

Date Ranges: Expiration 7/31/2021, Expiration 9/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84968

Status: Resolved

Manufacturer: Strides Pharma Science Limited

Sold By: pharmacies; healthcare providers

Manufactured In: India

Units Affected: 2576 bottles

Distributed To: Nationwide

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

Locate your white plastic bottle of Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), containing 1000 tablets.

Check the bottle label for NDC 64380-861-08 and verify if your lot number and expiration date match the following: Lot 7238958A (Exp 7/31/2021), Lot 7238257A (Exp 7/31/2021), or Lot 7239404A (Exp 9/30/2021).

If your bottle matches any of the affected lot numbers, contact your healthcare provider or pharmacist immediately for guidance on whether to continue your treatment or obtain a replacement.

Return any unused or affected product to your pharmacy for a refund and to ensure the defective tablets are properly handled.

Contact the manufacturer, Strides Pharma Inc., 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.