Exact FDA event identifier

Event 80980

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

Event summary

Timeline bucket: August 27, 2018
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: QuVa Pharma, 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

Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.

D-0003-2019

Recall number: D-0003-2019
Initiated: August 27, 2018
Classification: Class I
Status: Terminated
Recalling firm: QuVa Pharma, Inc.
Quantity: 528 bags

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Product may not have the active ingredient present in the bag.

Code information

Lot #:30000271, Exp 10/1/18

Distribution pattern

Nationwide to hospitals in USA