Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94619

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

Open FDA event record

Event summary

Timeline bucket
May 13, 2024
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
American Regent, 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

Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01

D-0507-2024
Recall number
D-0507-2024
Initiated
May 13, 2024
Classification
Class II
Status
Terminated
Recalling firm
American Regent, Inc.
Quantity
2,352 vials

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 product in addition to having out-of-specification results for impurities.

Code information

Lot #: 23061L1C0, Exp 1/31/2025

Distribution pattern

USA Nationwide