Exact FDA event identifier

Event 78035

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

Event summary

Timeline bucket: August 31, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Amneal Pharmaceuticals LLC

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

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7

D-0076-2018

Recall number: D-0076-2018
Initiated: August 31, 2017
Classification: Class II
Status: Terminated
Recalling firm: Amneal Pharmaceuticals LLC
Quantity: 14,000 vials

App-derived interpretation

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

Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter

Code information

Lot # AP160016; Exp. 05/18

Distribution pattern

MS, NC, OH, TX, UT