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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90898

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

Open FDA event record

Event summary

Timeline bucket
September 20, 2022
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

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.

D-1544-2022
Recall number
D-1544-2022
Initiated
September 20, 2022
Classification
Class III
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
1994 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

Code information

Lot 30027403, BUD 11/14/2022

Distribution pattern

Nationwide in the USA