FDAHealthJune 26, 2024
RemedyRepack Inc. — 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
⚠️ CGMP Deviations: Out of specification for dissolution
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 26, 2024
USA Nationwide
What's affected?
- 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
- Brand
- RemedyRepack Inc.
- Lot code
- J0758674-021824
Additional details
Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 142 blister cards, 30 per blister card.
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