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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

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

Agency Publication Date: October 1, 2020
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Summary

Strides Pharma Inc. is recalling 11,280 bottles of Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) because the medication failed dissolution specifications. This prescription drug, used to treat low potassium levels, may not release the medication into the body at the correct rate. The recall affects 100-count bottles that were distributed nationwide throughout the United States.

Risk

If the tablets do not dissolve as intended, the medication may be released too quickly or too slowly, which can prevent the patient from maintaining proper potassium levels and potentially lead to serious electrolyte imbalances. No specific injuries or adverse events were reported in the recall notice.

What You Should Do

  1. Check your medication bottle for the product name 'Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg)' in 100-count bottles.
  2. Verify if your bottle is affected by looking for NDC number 64380-860-06 and lot number 7240675A with an expiration date of 12/31/2021.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription, as you should not stop taking prescribed potassium without medical guidance.
  4. Return any unused tablets from the affected lot to your pharmacy for a refund and further instructions.
  5. Contact the manufacturer, Strides Inc., for additional information regarding this recall.
  6. For further questions, contact the FDA Consumer Complaint coordinator at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider 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: Strides Pharma Inc. Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets
Model:
NDC 64380-860-06
Recall #: D-0001-2021
Lot Numbers:
7240675A (Exp. 12/31/2021)
Date Ranges: Exp. 12/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86283
Status: Resolved
Manufacturer: Strides Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 11,280 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 ยท 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.