Exact FDA event identifier

Event 92737

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

Event summary

Timeline bucket: July 20, 2023
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: SCA Pharmaceuticals

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

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40

D-0945-2023

Recall number: D-0945-2023
Initiated: July 20, 2023
Classification: Class II
Status: Terminated
Recalling firm: SCA Pharmaceuticals
Quantity: 183 bags

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: due to shipment of rejected units.

Code information

Lot # 1223047134, Use By: 09/21/2023

Distribution pattern

KY and NJ