Drug Enforcement D-0611-2024

CGMP Deviations: Out of specification for dissolution

Status

Terminated

Classification

Class II

Report Date

July 24, 2024

Termination Date

January 31, 2025

Product Information

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
Product quantity
142 blister cards, 30 per blister card
Reason for recall
CGMP Deviations: Out of specification for dissolution
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
RemedyRepack Inc.
Address
625 Kolter Dr Ste 4

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0611-2024
Event ID
94888
Recall initiation date
June 26, 2024
Center classification date
July 18, 2024
Code info
Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025
More code info
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