Exact FDA event identifier

Event 92425

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

Event summary

Timeline bucket: May 30, 2023
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: SUN PHARMACEUTICAL INDUSTRIES 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

Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01

D-0891-2023

Recall number: D-0891-2023
Initiated: May 30, 2023
Classification: Class II
Status: Terminated
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Quantity: 12960 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent drug

Code information

Lot # BAD0089A, Exp 01/2025; BAD0330A, Exp 07/2025

Distribution pattern

USA nationwide