Exact FDA event identifier

Event 89402

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

Event summary

Timeline bucket: January 11, 2022
Product types: Drug
Classifications: Class II
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

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1

D-0369-2022

Recall number: D-0369-2022
Initiated: January 11, 2022
Classification: Class II
Status: Terminated
Recalling firm: Exela Pharma Sciences LLC
Quantity: 18,960 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: C0001088/P0001317, Exp. Date 08/2023

Distribution pattern

Nationwide within the United States