Reported Feb 12, 2025 · Ongoing

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters),…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606

Is this the product you have?

  • Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only
  • Distributed byAurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India
  • Distributed byMAJOR PHARMACEUTICALS, Livonia, MI 48152
  • NDC0904-7216-61
Lot codes and dates
    • Lot# T05224
    • Exp. 02/2026
Amount recalled
6997 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:22 PM UTC

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