Exact FDA event identifier

Event 73434

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

Event summary

Timeline bucket: March 01, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Sagent Pharmaceuticals 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

Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82

D-0780-2016

Recall number: D-0780-2016
Initiated: March 01, 2016
Classification: Class II
Status: Terminated
Recalling firm: Sagent Pharmaceuticals Inc
Quantity: 37,450 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Cross contamination with other products: metronidazole

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross contamination with other products: metronidazole

Code information

Lot #: 40608, Exp 5/17

Distribution pattern

Nationwide and Puerto Rico