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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84910

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

Open FDA event record

Event summary

Timeline bucket
February 07, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AuroMedics Pharma 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

Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20

D-0852-2020
Recall number
D-0852-2020
Initiated
February 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
AuroMedics Pharma LLC
Quantity
30432 bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie

Code information

Lot #: SM8719040-A, Exp. Date 02/2021

Distribution pattern

Nationwide within the United States