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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85831

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

Open FDA event record

Event summary

Timeline bucket
June 11, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hikma Pharmaceuticals USA 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

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 HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01

D-1308-2020
Recall number
D-1308-2020
Initiated
June 11, 2020
Classification
Class II
Status
Terminated
Quantity
82,426 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

Code information

Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021

Distribution pattern

Nationwide within the United States

drug · product 2 of 2

Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01

D-1309-2020
Recall number
D-1309-2020
Initiated
June 11, 2020
Classification
Class II
Status
Terminated
Quantity
17,998 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

Code information

Lot #:AC0231A, exp. date 08/2021

Distribution pattern

Nationwide within the United States