Exact FDA event identifier

Event 86288

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

Event summary

Timeline bucket: May 05, 2020
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Exela Pharma Sciences LLC

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 Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4

D-1585-2020

Recall number: D-1585-2020
Initiated: May 05, 2020
Classification: Class III
Status: Terminated
Recalling firm: Exela Pharma Sciences LLC
Quantity: 23,775 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Short Fill

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Short Fill

Code information

Lot #P0000471, Catalog #2020TS002, Exp Date: 04/2021

Distribution pattern

Nationwide and Puerto Rico