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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94888

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 26, 2024
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
RemedyRepack Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0611-2024
Recall number
D-0611-2024
Initiated
June 26, 2024
Classification
Class II
Status
Terminated
Recalling firm
RemedyRepack Inc.
Quantity
142 blister cards, 30 per blister card

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Out of specification for dissolution

Code information

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

Distribution pattern

USA Nationwide