Exact FDA event identifier

Event 82210

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

Event summary

Timeline bucket: February 01, 2019
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Mylan Institutional 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

Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30

D-1059-2019

Recall number: D-1059-2019
Initiated: February 01, 2019
Classification: Class I
Status: Terminated
Recalling firm: Mylan Institutional Inc
Quantity: 11,964 cartons of 30 vials

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: particulate matter identified as copper salts

Code information

Lot #: APB032, APB033, Exp. April 2019

Distribution pattern

Nationwide in the United States