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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80254

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 08, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ingenus Pharmaceuticals 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

Complete imported group

Every recalled product in this event

2 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 2

Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.

D-0890-2018
Recall number
D-0890-2018
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Quantity
34964 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: High out of specification assay value results for potency.

Code information

Lot #: 17034-1, 17035-1, 17036-1; Exp. 08/19

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.

D-0891-2018
Recall number
D-0891-2018
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Quantity
14089 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: High out of specification assay value results for potency.

Code information

Lot #: 17034-2, 17035-2, 17036-2; Exp. 08/19

Distribution pattern

Nationwide in the USA