FDA recall D-0611-2024

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

Reason for recall

CGMP Deviations: Out of specification for dissolution

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2024-06-26

Report date

2024-07-24

Termination date

2025-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0611-2024