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Class II: temporary or reversible health riskTerminated

RemedyRepack Potassium Chloride Micro 10mEq K Recall

Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister c…

RemedyRepack Inc. · Indiana, PA

Risk level
Class II
Reported by FDA
Jul 24, 2024
Recall ID
D-0611-2024
Check your lot numberHow we source this data

Summary

RemedyRepack recalled Potassium Chloride Micro 10mEq K starting Jun 26, 2024. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0611-2024 on Jul 24, 2024. Reason: CGMP Deviations: Out of specification for dissolution. Status: Terminated.

Why it was recalled

CGMP Deviations: Out of specification for dissolution

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0611-2024
Classification
Class II
Status
Terminated
Recall initiated
Jun 26, 2024
FDA report date
Jul 24, 2024
Quantity
142 blister cards, 30 per blister card
Recall type
Voluntary: Firm initiated
Recalling firm
RemedyRepack Inc.

Original FDA data

Every field from FDA enforcement report D-0611-2024, exactly as published.

Show all FDA fields
City
Indiana
State
PA
Status
Terminated
Country
United States
Event ID
94888
Address
625 Kolter Dr Ste 4
Code information
Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025
Postal code
15701-3571
Report date
Jul 24, 2024
Product type
Drugs
Recall number
D-0611-2024
Classification
Class II
Recalling firm
RemedyRepack Inc.
Product quantity
142 blister cards, 30 per blister card
Termination date
Jan 31, 2025
Reason for recall
CGMP Deviations: Out of specification for dissolution
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
USA Nationwide
Recall initiation date
Jun 26, 2024
Initial firm notification
E-Mail
Center classification date
Jul 18, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0611-2024, published Jul 24, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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