Exact FDA event identifier

Event 91767

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

Event summary

Timeline bucket: February 23, 2023
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Nephron Sc 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

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

Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01

D-0364-2023

Recall number: D-0364-2023
Initiated: February 23, 2023
Classification: Class II
Status: Terminated
Recalling firm: Nephron Sc Inc
Quantity: 325,080 vials

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: Potential product carryover.

Code information

Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023

Distribution pattern

United States