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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75445

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

Open FDA event record

Event summary

Timeline bucket
October 06, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Actavis Elizabeth 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

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

NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10

D-0143-2017
Recall number
D-0143-2017
Initiated
October 06, 2016
Classification
Class III
Status
Terminated
Recalling firm
Actavis Elizabeth LLC
Quantity
27,517 bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Tablets/Capsules

Code information

Lot # 0598B151; Exp 03/18

Distribution pattern

US