Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules recall
FDA recall D-0611-2024 · initiated Jun 26, 2024
RemedyRepack Inc. recalled Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules in Jun 2024 — an FDA Class II recall (D-0611-2024) because CGMP Deviations: Out of specification for dissolution.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Out of specification for dissolution
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 142 blister cards, 30 per blister card
Details
- Product
- 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
- Recalling company
- RemedyRepack Inc.
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jun 26, 2024
- FDA report date
- Jul 24, 2024
Frequently asked
- Was Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules recalled?
- RemedyRepack Inc. recalled Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules in Jun 2024 — an FDA Class II recall (D-0611-2024) because CGMP Deviations: Out of specification for dissolution. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0611-2024 was: CGMP Deviations: Out of specification for dissolution
- Is a recalled Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0611-2024.