Exact FDA event identifier

Event 87452

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

Event summary

Timeline bucket: March 04, 2021
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Teva Pharmaceuticals 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

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

Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01

D-0309-2021

Recall number: D-0309-2021
Initiated: March 04, 2021
Classification: Class III
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA
Quantity: 1,416 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Impurity/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.

Code information

Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021

Distribution pattern

Distributed Nationwide in the USA.