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Drug FDA Class II Terminated Failed specifications

Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03

RemedyRepack Inc. Published Jul 24, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact RemedyRepack Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: Out of specification for dissolution

Hazards

Failed Dissolution · primary

Affected products (1)

Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03

142 blister cards, 30 per blister card

Code info: Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 26, 2024
  2. Published
    Jul 24, 2024
  3. Terminated
    Jan 31, 2025
Recall number
D-0611-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.