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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89869

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

Open FDA event record

Event summary

Timeline bucket
March 17, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aurolife 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

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.

D-0736-2022
Recall number
D-0736-2022
Initiated
March 17, 2022
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
4080 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: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.

Code information

Lot: 01421008A1, Exp 03/2023

Distribution pattern

Nationwide in the USA and Puerto Rico