Exact FDA event identifier

Event 75997

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

Event summary

Timeline bucket: December 16, 2016
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Aurobindo Pharma USA 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

Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00

D-0470-2017

Recall number: D-0470-2017
Initiated: December 16, 2016
Classification: Class III
Status: Terminated
Recalling firm: Aurobindo Pharma USA Inc
Quantity: 29800 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

Code information

Lot #: CPO160028, Exp. June 2018

Distribution pattern

Nationwide in US