Exact FDA event identifier

Event 88402

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

Event summary

Timeline bucket: August 05, 2021
Product types: Drug
Classifications: Class III
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

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

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

D-0771-2021

Recall number: D-0771-2021
Initiated: August 05, 2021
Classification: Class III
Status: Terminated
Recalling firm: Hikma Pharmaceuticals USA Inc.
Quantity: 1,152 vials

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Mislabeling

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not elsewhere classified: Mislabeling

Code information

BL0018

Distribution pattern

USA nationwide