PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 24, 2024 Initiated: June 26, 2024 #D-0611-2024

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

Details

Recalling Firm
RemedyRepack Inc.
Units Affected
142 blister cards, 30 per blister card
Distribution
USA Nationwide
Location
Indiana, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by RemedyRepack Inc.. Units affected: 142 blister cards, 30 per blister card.
Why was this product recalled?
CGMP Deviations: Out of specification for dissolution
Which agency issued this recall?
This recall was issued by the FDA Drug on July 24, 2024. Severity: Moderate. Recall number: D-0611-2024.