Exact FDA event identifier

Event 80453

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

Event summary

Timeline bucket: July 03, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medi-Fare Drug and Home Health Center

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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 For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007

D-0919-2018

Recall number: D-0919-2018
Initiated: July 03, 2018
Classification: Class II
Status: Terminated
Recalling firm: Medi-Fare Drug and Home Health Center
Quantity: 1116 syringes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.

Code information

Lot: 20180522@1 Exp.: 08/20/18

Distribution pattern

Texas only