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Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx on...

FDA Recall #D-0611-2024 — Class II — June 26, 2024

Recall #D-0611-2024 Date: June 26, 2024 Classification: Class II Status: Terminated

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

Reason for Recall

CGMP Deviations: Out of specification for dissolution

Recalling Firm

RemedyRepack Inc. — Indiana, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

142 blister cards, 30 per blister card

Distribution

USA Nationwide

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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