CLASS II Drug recall · Reported 24 Jul 2024 · FDA Enforcement Report
Potassium Chloride Micro 10mEq recalled by RemedyRepack
RemedyRepack is recalling Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules blister card, distributed nationwide in the US. The recall was initiated on 26 Jun 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0611-2024
- FDA event ID
- 94888
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jun 2024
- FDA classified
- 18 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Jun 2024 | Recall initiated by company | |
| 18 Jul 2024 | Classified by FDA | +22 days |
| 24 Jul 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Out of specification for dissolution
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Out of specification for dissolution
Which lots are affected?
Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RemedyRepack
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Carvedilol, QTY: per Blister Pack ( blister cards) recalled | RemedyRepack | Nitrosamine Impurity | FL |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Phenazopyridine HCl, 100mg tablets recalled by RemedyRepack | RemedyRepack | Packaging Defects | PA |