Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69485

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

Open FDA event record

Event summary

Timeline bucket
October 03, 2014
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

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

Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195

D-0027-2015
Recall number
D-0027-2015
Initiated
October 03, 2014
Classification
Class II
Status
Terminated
Quantity
69,050 vials

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling the product with the incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.

Code information

Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16

Distribution pattern

Nationwide and Puerto Rico