Exact FDA event identifier

Event 70375

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

Event summary

Timeline bucket: January 23, 2015
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Mylan Institutional LLC

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

Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10

D-0413-2015

Recall number: D-0413-2015
Initiated: January 23, 2015
Classification: Class III
Status: Terminated
Recalling firm: Mylan Institutional LLC
Quantity: 78,090 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 Drug and Failed Impurities/Degradation Specifications

Code information

Lot #: UW301, UW302, Exp 02/15; UW303, UW304, UW305, UW306, Exp 04/15

Distribution pattern

Nationwide