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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97909

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

Open FDA event record

Event summary

Timeline bucket
October 31, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cipla Limited

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

Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96

D-0197-2026
Recall number
D-0197-2026
Initiated
October 31, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cipla Limited
Quantity
4,438 10x1mL cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Stability Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Observed OOS results: eg results for colour index

Code information

Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025

Distribution pattern

Nationwide in the USA