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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81891

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

Open FDA event record

Event summary

Timeline bucket
January 03, 2019
Product types
Drug
Classifications
Class I
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

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

Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]

D-0372-2019
Recall number
D-0372-2019
Initiated
January 03, 2019
Classification
Class I
Status
Terminated
Quantity
12,534 cartons, 125,340 vials

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

Code information

Lot #: JKS0443A, JKS0444A, JKS0477A, EXP 03/2019

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton]

D-0373-2019
Recall number
D-0373-2019
Initiated
January 03, 2019
Classification
Class I
Status
Terminated
Quantity
1,384 cartons, 13,840 vials

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

Code information

Lot #: JKS0400A, EXP 03/2019

Distribution pattern

Nationwide in the USA