FDA-Drug2024-07-24Class II

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

RemedyRepack Inc.
Hazard

CGMP Deviations: Out of specification for dissolution

Sold states
USA Nationwide
Affected count
142 blister cards, 30 per blister card
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
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

Official notice

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

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