Recall events
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Event 81891
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
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
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
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17357]
FDA event record
· Exact recall-number query on openFDA
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
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16865]
FDA event record
· Exact recall-number query on openFDA
