← FDA ENFORCEMENT
D-0611-2024Class II

RemedyRepack Inc.

Recalling firm
RemedyRepack Inc.
Product type
Drug
Status
Terminated
Report date
2024-07-24
Distribution
USA Nationwide
Firm state
PA
Product quantity
142 blister cards, 30 per blister card
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

CGMP Deviations: Out of specification for dissolution

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

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.