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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81644

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

Open FDA event record

Event summary

Timeline bucket
November 21, 2018
Product types
Drug
Classifications
Class III
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

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 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05

D-0295-2019
Recall number
D-0295-2019
Initiated
November 21, 2018
Classification
Class III
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
168 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

Code information

Lot #:10016014 Exp. 01/06/2019

Distribution pattern

CA only