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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64102

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

Open FDA event record

Event summary

Timeline bucket
January 22, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fresenius Kabi USA LLC (FK USA)

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

IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.

D-915-2013
Recall number
D-915-2013
Initiated
January 22, 2013
Classification
Class II
Status
Terminated
Quantity
23,672 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Active pharmaceutical ingredient is precipitating in product solution.

Code information

Lot #: 872CZ00101, Exp 12/13

Distribution pattern

Nationwide